Dashboard
TGA Stage 1 Live ⚑ SYNTHETIC DEMO
2
Open recall cases
Action required
1
In progress
Evidence collection
5
Closed · quarter
Verified
3
Open exceptions
Risk decisions pending
86%
Verified closure rate
ROQ Level 2
⚑ Reportability workflow — 10-day serious-event route
AE-2026-0007 — RESOLUTE ONYX Coronary Stent
Serious adverse event · Class III · ASDER or IRIS route
Deadline: 26 March 2026 — ACT TODAY
MA-2026-0012 — Persona Knee · Zimmer Biomet
Market action — no confirmed local adverse event yet
Local governance workflow — assess if event occurred
3 new notices detected in auto-import queue — TGA scrape + openFDA signals. Needs review before case creation.
Recent recall cases
TGA / AE refDeviceClassRouteStatusDeadline
AE-2026-0007
RC-2026-RN-01847		RESOLUTE ONYX Coronary Stent
Medtronic · ARTG 173849		Class IIIASDER/IRIS · 10-dayOpen26 Mar 2026
MA-2026-0012
RC-2026-RN-01920		Persona Knee — Femoral Component
Zimmer Biomet · ARTG 218904		Class IIIMarket actionOpenAssess event
MA-2026-0008
RC-2026-RN-01791		Triathlon Knee — Tibial Insert
Stryker · ARTG 209841		Class IIIMarket actionIn progressInternal
AE-2025-0084
RC-2026-RN-01653		BD Alaris Infusion — SW v12.x
Becton Dickinson · ARTG 196204		Class IIbVol. IRIS filedClosed12 Mar 2026Verified ✓

All recall cases

St Catherine's Private · 8 cases this period

RefTGA referenceDeviceRecall classRoute / obligationUnits AUStatusDeadline / note

Auto-import queue

Notices detected from TGA recall database (daily scrape) and openFDA global device signals. Review each notice before creating a case — the platform does not auto-create cases from import data.

Review required before case creation. Each imported notice must be reviewed by a quality or biomedical lead to confirm: (a) whether the device is on-site, (b) whether a reportable adverse event has occurred, and (c) which reporting route applies. The import queue is a prompt, not an automatic case.
TGA RECALL DATABASE
tga.gov.au · HTML scrape
Last run: Today 06:14 AEDT
New notices detected: 2
Scrape status: Healthy
OPENFDA DEVICE RECALL API
api.fda.gov · REST API
Last run: Today 06:16 AEDT
AU-market device signals: 1
API status: 200 OK
MANUFACTURER PORTAL
Manual / email intake
Last submitted: 22 Mar 2026
New items: 0
No email integration yet

Review queue — 3 items pending

TGA
RC-2026-RN-02010 — DePuy Synthes CORAIL Hip Stem — Johnson & Johnson
Class III · ARTG 174288 · ~640 units AU est. · Scrape detected: Today 06:14 · Class II recall initiated by sponsor — dimensional tolerance issue on stem coating. No adverse event reported yet.
⚑ Confirm device is on-site · determine if adverse event has occurred · select route
TGA
RC-2026-RN-02004 — Siemens Healthineers ACUSON Ultrasound — Probe Cable
Class IIb · ARTG 201344 · ~320 units AU est. · Scrape detected: Yesterday 06:08 · Class III hazard alert — cable insulation may discolour under UV sterilisation. No injury reported.
Market action / hazard alert — voluntary governance workflow, assess if IRIS needed
openFDA
FDA Z-1988-2026 — Integra LifeSciences DuraGen Dural Graft — Lot correlation signal
FDA Class II recall initiated · Device registered in AU as ARTG 218802 (estimated) · ~88 units potentially in AU · openFDA signal: device has AU-registered equivalent — TGA action may follow.
Early-warning FDA signal — verify ARTG status · watch TGA database for corresponding action
Note on TGA scraping and openFDA use. The TGA recall database is scraped from publicly available HTML pages at tga.gov.au. Commercial use of TGA data for a SaaS platform should be confirmed with your AU counsel as part of the G1/G2 memo scope. openFDA data is released under a public domain licence (Creative Commons CC0). Cross-referencing FDA recall events to ARTG-registered devices is a manual confirmation step — the platform flags signals only, it does not substitute for TGA's own notification pathway.

Recall Watch — weekly bulletin

Week ending 27 March 2026 · AU Edition · Synthetic demo data

Subscribe free →
2 notices involve Stage 1 reportable device classes. For each, assess whether a serious adverse event has occurred at your facility. If yes: ASDER or IRIS within 10 days of becoming aware. Recall Watch does not replace TGA's own notification to your facility.

Evidence packs — RCES artefact classes

AE-2025-0084 — BD Alaris Infusion System SW v12.x · Closed 8 artefact classes evidenced ✓
📄
TGA recall notice RC-2026-RN-01653 — original communication
A-01 Notice documentation
✓ Uploaded
📋
Internal distribution confirmation — ICU, HDU, Oncology, ED, Surgical Wards notified
A-02 Internal operational comms record
✓ Uploaded
🔢
Device inventory — 2,840 affected units by ward · exported from BMMS via CSV
A-03 Inventory reconciliation
✓ Uploaded
✅
Software patch V12.1.3 deployment — IT sign-off document
A-05 Action completion evidence
✓ Uploaded
📸
Pump-by-pump patch verification confirmation — 2,837 units
A-06 Device-level verification
✓ Uploaded
📁
Operational notification log — departments confirmed · local record ref: OPS-2026-0153
A-08 Operational notification record (reference pointer — local record retained)
✓ Reference
⚠
Exception log — 3 pumps in external loan · return confirmed 15 Mar 2026
A-09 Exception documentation
✓ Uploaded
🔏
Closure sign-off — Quality Lead role · Site A · 12 Mar 2026 14:42 AEDT
A-11 Verified closure record
✓ Signed
AE-2026-0007 — RESOLUTE ONYX Coronary Stent · Open 4 / 11 artefacts · ⚑ Reporting deadline today
10-day ASDER/IRIS reporting route active. Evidence pack must support submission. Incomplete evidence does not delay reporting — submit initial report and supplement as evidence is gathered.
📄
TGA recall notice RC-2026-RN-01847 — original communication
A-01 Notice documentation
✓ Uploaded
📋
Internal distribution — Cardiac Cath Lab, Theatre notified
A-02 Internal comms record
✓ Uploaded
🔢
Device inventory — lot-level count in progress · BMMS export underway
A-03 Inventory reconciliation
⏳ In progress
🔒
Quarantine certificate — affected stock secured in Cath Lab store
A-04 Action initiation evidence
✓ Uploaded
📦
Return-to-sponsor — Medtronic collection not yet confirmed
A-05 Action completion evidence
✗ Pending
🔏
Closure sign-off — pending action completion and exception resolution
A-11 Verified closure record
✗ Not yet

Exception log — open risk decisions

Devices not recovered or resolved under the recall action. Each exception requires a documented reason code, risk decision, and authorised sign-off before the case can be marked as closed.

3 exceptions require risk decisions and sign-off. Exceptions do not prevent reporting — they must be disclosed in the ASDER/IRIS report and the audit pack. Each exception increases the risk profile of the closure claim.
AE-2026-0007 · Lot LN2024-A114 · 2 units · Cardiac Cath Lab
RESOLUTE ONYX Coronary Stent — units already deployed before notice received
High riskPending sign-off
Units were used in a procedure completed on 14 March 2026 — prior to the facility becoming aware of the recall notice on 16 March. Clinical governance record retained locally under reference CG-4412. The hospital's duty of care and patient follow-up obligation remains with the clinical team — this platform holds the operational record reference only.
Reason code: Device used before notice awareness Risk decision: High — local clinical governance file CG-4412 Owner: Quality Lead — Cath Lab Site A
AE-2026-0007 · Lot LN2024-A115 · 1 unit · Consignment stock
RESOLUTE ONYX Coronary Stent — unit on loan to Metro General Hospital
Medium riskIn transit
Unit was part of a consignment loan to Metro General Hospital. Return initiated 20 March 2026. Metro General's biomedical team confirmed receipt of recall notice. Return expected by 2 April 2026 — tracking reference MET-LOAN-0441.
Reason code: Unit at another facility — tracked return Risk decision: Medium — return confirmed and tracked Owner: Site Coordinator — Cath Lab
MA-2026-0008 · Lot TKR-2025-AUS-441 · 1 unit · Orthopaedics
Triathlon Knee — Tibial Insert — device used in arthroplasty procedure
High riskPending sign-off
Device used in a total knee replacement procedure on 12 February 2026 — before recall notice received. The implant remains in situ. Patient follow-up is managed by the treating orthopaedic team and retained in the hospital's clinical governance system under reference ORTHO-209. This platform holds the operational exception record only — clinical follow-up responsibility does not transfer to this platform.
Reason code: Implanted device — clinical follow-up active Risk decision: High — enhanced surveillance, local ref ORTHO-209 Owner: Orthopaedic Lead — Site A

Route decision — adverse event & recall triage

Use this guided triage to determine whether a TGA mandatory reporting obligation applies, and which submission route to use. This tool guides the decision — it does not replace clinical or legal judgement. All decisions must be documented.

TGA framework — Stage 1 (21 March 2026 to 31 March 2028). Mandatory 10-day reporting applies to death or serious deterioration in health involving the current Stage 1 reportable device classes. Reports can be made via ASDER or IRIS. If already reported via IRIS, do not duplicate via ASDER. Near-miss and treatment-related incidents become mandatory from Stage 2 (1 April 2028) — keep internal records before then.
1
Did this event result in the death or serious deterioration in the health of a person?
2
Was the device involved a Class III medical device or an IVD Class 4 device?
3
Is the event unusual or unexpected — would it benefit from prompt IRIS notification even if not a mandatory Stage 1 event?
⚑ 10-day mandatory reporting route — ASDER or IRIS

A Stage 1 mandatory adverse event report is required. Report via ASDER (the TGA's Adverse Events, Safety and Device regulatory reporting portal) or IRIS (the Incident Reporting and Investigation Scheme). If already reported via IRIS, do not submit a duplicate ASDER report for the same incident. Initial report is due within 10 calendar days of first becoming aware. Your evidence pack does not need to be complete before submitting — submit the initial report, then supplement as investigation continues.

📨 Voluntary IRIS notification — unusual or unexpected incident

This event does not appear to meet the current Stage 1 mandatory reporting threshold (Class III / IVD Class 4 + death or serious deterioration), but the event is unusual or unexpected. Voluntary IRIS notification is appropriate and supports post-market surveillance. Document the decision rationale, run the internal governance workflow, and record the IRIS notification reference in the case evidence pack.

◈ Market action / recall governance workflow

No death or serious deterioration identified at this facility. This is a market action (sponsor-initiated recall) or routine recall notice requiring internal governance, inventory triage, and evidence-backed closure. No Stage 1 mandatory report is triggered at this stage. Continue the recall-governance workflow: device triage → action tracking → evidence pack → verified closure. If a device-related adverse event subsequently occurs, reassess and re-run this triage.

◎ Not currently a Stage 1 mandatory event — internal governance

Based on device class, the event does not currently fall within the Stage 1 mandatory reporting scope. Run the internal governance and recall-closure workflow. Monitor for any change in event outcome — if death or serious deterioration is later confirmed, reassess immediately. Near-miss and treatment-related incident mandatory reporting applies from Stage 2 (1 April 2028).

TGA reporting routes — quick referenceStage 1 · 21 Mar 2026
10-DAY MANDATORY — ASDER OR IRIS
  • ✓ Death or serious deterioration in health
  • ✓ Involving Class III or IVD Class 4 device
  • ✓ Stage 1 in force from 21 March 2026
  • ✓ ASDER or IRIS — do not duplicate same incident
  • ✓ Initial report due within 10 calendar days
OTHER ROUTES & TIMELINES
  • ◎ Unusual/unexpected incident → voluntary IRIS now
  • ◎ Near miss / treatment-related → mandatory from Stage 2 (1 Apr 2028)
  • ◎ Market action / sponsor recall → governance workflow only
  • ◎ Centralised reporting via state/group pathway may satisfy obligation
  • ◎ Stage 2: 1 April 2028 · Stage 3: 1 April 2030

KPI metrics — ROQ maturity measurement

18.4h
Time-to-Identify (TTI)
Median · notice issue to site intake · target <24h
36.2h
Time-to-Action (TTA)
Median · intake to first action assigned · target <48h
85.7%
Verified Closure Rate (VCR)
Closed cases with verified completion this quarter
19
Evidence Burden (EB)
RCES artefact classes — full set per closed case
3
Open exceptions (EoC)
Devices not recovered — pending documented risk decisions
ROQ 2
ROQ maturity level
Structured / evidence-collecting → targeting Level 3
Verified closure rate by device category
Infusion systems
100%
Patient monitoring
100%
IVD / Diagnostic
100%
Orthopaedic implants
50%
Cardiovascular
0% — serious event open
ROQ maturity — progress from Level 2 to Level 3Current: Structured / evidence-collecting
Structured notice intakeComplete ✓
Reporting route decision documentedComplete ✓
Evidence pack — RCES artefact alignment75%
Exception log with documented risk decisions60%
Verified closure sign-off workflowComplete ✓
KPI dashboard and periodic reportingComplete ✓
UDI capture (Phase 2 — Jul 2026)Not started
Multi-site group dashboard (Phase 2)Not started
KPI trend — last 3 quarters
MetricQ3 2025Q4 2025Q1 2026Trend
Time-to-Identify (TTI) — median hours42.1h28.4h18.4h↓ Improving
Time-to-Action (TTA) — median hours68.3h48.2h36.2h↓ Improving
Verified Closure Rate (VCR)62%74%86%↑ Improving
Open exceptions at quarter end853↓ Improving
RCES artefact classes per closed case6.27.88.4↑ Improving
ROQ maturity level11–22→ Stable

Audit export — case closure pack

Recall Closure Audit Pack

AE-2025-0084 · RC-2026-RN-01653 · BD Alaris Infusion System SW v12.x · Generated 27 March 2026 14:22 AEDT · CONFIDENTIAL
VERIFIED CLOSED ✓

Case summary

TGA referenceRC-2026-RN-01653
Internal refAE-2025-0084
Recall typeClass II Medical Device Recall — sponsor-initiated
DeviceBD Alaris System — Infusion Pump Module (software defect SW V12.0.0–V12.1.2)
SponsorBecton Dickinson Pty Ltd · ARTG 196204
Notice received11 February 2026
Units affected2,840 (ICU, HDU, Oncology, ED, Surgical Wards · BMMS export reconciled)
Reportability assessmentRoute triage completed 12 Feb 2026 · No Stage 1 mandatory event identified · No death or serious deterioration reported · Voluntary IRIS report filed 9 March 2026 as unusual incident (unusual multi-site software issue) · IRIS ref: IRIS-2026-AUS-4412

RCES evidence index — artefact classes evidenced

✓ A-01 Notice documentation ✓ A-02 Operational comms record ✓ A-03 Inventory reconciliation ✓ A-05 Action completion ✓ A-06 Device verification ✓ A-08 Operational notification ref ✓ A-09 Exception record ✓ A-11 Verified closure — A-04 not applicable — A-07 not applicable — A-10 not applicable

Action log summary

Action 1Software patch V12.1.3 — deployed across all 2,840 affected units by Biomedical Engineering Lead · completed 8 Mar 2026
Action 2Manual monitoring protocol activated — ICU, HDU, Oncology · active until patch confirmed · Site Coordinator Role · completed 14 Feb 2026
Action 3Department notifications — all affected wards confirmed receipt · Operational notification log ref OPS-2026-0153

Exceptions summary

Exceptions3 units — consignment loan, returned 15 March 2026 and patched on return. No unresolved exceptions at closure.

Verified closure

DecisionClosed — all affected units patched and verified, exceptions resolved
Authorised byQuality Lead role — Site A
Timestamp12 March 2026 · 14:42:09 AEDT
RCES conformanceL1 — 8 of 11 artefact class types evidenced in-platform (3 N/A for this recall type)
Submission proofVoluntary IRIS filed 9 March 2026 · IRIS ref IRIS-2026-AUS-4412 · no mandatory ASDER obligation triggered

ROQAIAH Recall Ready · Synthetic demo · ROQ-AIAH-STD-1000 v0.1.0 · Not for regulatory submission · Patient-level records are retained locally by the hospital under its own governance obligations and are not held in this platform

Network view — group dashboard

Illustrative multi-site view · Phase 2 feature · 3 hospitals shown

Tier 1.5 — Network feature
This view is available in the Tier 1.5 Network plan. It provides a consolidated KPI view across all sites in your hospital group, with site-level drill-down and group-level audit-pack export.
3
Sites monitored
Group view
4
Open cases — group
Action required
83%
Group closure rate
All sites
5
Open exceptions — group
Decisions pending
St Catherine's Private
SYNTHETIC GROUP · SITE A
Open: 2
Closed: 5
Exceptions: 3
VCR: 86%
ROQ: Level 2
Metro General Hospital
SYNTHETIC GROUP · SITE B
Open: 1
Closed: 8
Exceptions: 2
VCR: 89%
ROQ: Level 2
Southern Cross Clinic
SYNTHETIC GROUP · SITE C
Open: 1
Closed: 3
Exceptions: 0
VCR: 75%
ROQ: Level 1
Onboarding in progress
Australian hospital network context

Australia's major private hospital groups — Ramsay Health Care (72 hospitals), Healthscope (38 hospitals), Luye Medical (formerly St John of God's former sites), and Nexus Hospitals — operate centralised biomedical engineering and quality governance functions. These groups are the primary Tier 1.5 targets for ROQAIAH's network plan.

Biomedical asset management systems (AU)
  • Nuvolo (Maximo Health) — Ramsay, Healthscope major sites
  • Infor EAM — some private group facilities
  • SAP PM modules — NSW Health, QLD Health, state systems
  • Spreadsheets / PMS modules — smaller independents
ROQAIAH integration path
  • Phase 1CSV upload template → device triage (any BMMS)
  • Phase 2Nuvolo API read → Ramsay/Healthscope
  • Phase 3State health API agreements (public hospitals)

New recall case intake

Run the route decision before or during intake. This form creates an operational case record — it does not automatically submit a report to TGA.

Case detailsDraft
Capture UDI now even before 1 July 2026 to prepare for the phase-in requirement.
Route quick guide
10-day mandatory
Death / serious deterioration · Class III or IVD Class 4 · Stage 1 from 21 Mar 2026
Voluntary IRIS
Unusual / unexpected incident · prompt notification · don't duplicate mandatory
Market action only
Sponsor recall · no local adverse event · internal governance workflow
Stage 2 (1 Apr 2028)
Near miss / treatment-related incidents become mandatory. Keep records now.
Intake checklist
  • ☐ TGA reference number captured
  • ☐ Device class confirmed (ARTG checked)
  • ☐ Route decision documented
  • ☐ Affected wards / departments listed
  • ☐ Lot numbers or SW versions recorded
  • ☐ Action owner role assigned
  • ☐ Quality / reporting lead notified
  • ☐ 10-day clock started if applicable

Device inventory — CSV import

Export affected device records from your biomedical equipment management system (Nuvolo, Infor EAM, or spreadsheet), then upload using the template below. This eliminates manual re-entry and reduces inventory triage time from hours to minutes.

Step 1 — Download CSV template

The template matches ROQAIAH's device triage schema. Column headers must be preserved exactly. Your BMMS export will typically require a column rename step.

device_name, manufacturer, model_number, artg_number, udi, serial_number_or_range, quantity, ward_department, site
BMMS export tips: Nuvolo → Asset Register → Export → filter by device class/recall lot · Infor EAM → Equipment → Export CSV · Spreadsheet → use VLOOKUP against lot number list
Step 2 — Upload populated template
📂

Drop CSV file here or click to browse

Accepts .csv files up to 5MB · UTF-8 encoding · Max 10,000 rows

Integration roadmap
Phase 1 · Now
CSV upload (any BMMS)

Template-based upload works with any biomedical equipment management system or spreadsheet. No integration required. Reduces manual re-entry by ~80%.

Phase 2 · 2026
Nuvolo API read (Ramsay / Healthscope)

Direct API read from Nuvolo asset register for Ramsay (72 hospitals) and Healthscope (38 hospitals). Recall lot number cross-reference automated. Requires vendor agreement with Nuvolo. Target: Q4 2026.

Phase 3 · 2027
State health system integration (public hospitals)

SAP PM integration for NSW Health, QLD Health, and other state systems. Requires state health IT procurement agreements. IRAP assessment likely required.