Tempus Pro Patient Monitor — Class II medical device recall Z-1666-2025
Ongoing recall by Remote Diagnostic Technologies Ltd., reported 2025-04-30, distributed nationwide. software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope
| Recall number | Z-1666-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remote Diagnostic Technologies Ltd., Farnborough, N/A, United Kingdom |
| Recall initiated | 2025-04-16 |
| Classified | 2025-04-24 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 6,961 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05060472440013, 05060472440020, 05060472440624, 05060472440655, 05060472441027, 05060472441058, 05060472442901, 05060472442918, 05060472442925, 05060472442932 |
| Model numbers | 00-1004-R |
Product
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Reason for recall
software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1666-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.