Philips Tempus Pro Patient Monitor — Class II medical device recall Z-1027-2026
Ongoing recall by Remote Diagnostic Technologies Ltd., reported 2026-01-14, distributed nationwide. Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements h
| Recall number | Z-1027-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remote Diagnostic Technologies Ltd., Farnborough, United Kingdom |
| Recall initiated | 2025-11-26 |
| Classified | 2026-01-08 |
| Reported by FDA | 2026-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 7,129 |
| UPC / GTIN / UDI-DI | 05060472440013, 05060472440020, 05060472440624, 05060472440655, 05060472441027, 05060472441058, 05060472442901, 05060472442918, 05060472442925, 05060472442932 |
| Serial numbers | 30036, 30051, 30052, 30063, 30064, 30076, 30077, 30080, 30081, 30082, 30083, 30084, 30085, 30093, 30094, 30096, 30098, 30099, 30100, 30110, 30201, 30202, 30203, 30215, 30217 and 475 more |
| Model numbers | 00-1004, 00-1004-R, 00-1007, 00-1007-R, 00-1024-R, 00-1026-R, 2-CHANNELIBP |
Product
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Reason for recall
Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.
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-1027-2026. 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.