[pending] Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-
Pending LLM rewrite. Source: FDA_DEVICE Z-1027-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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
- Manufacturer
- Remote Diagnostic Technologies Ltd.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- REF/UDI-DI: 00-1004/05060472440624
- 00-1007/05060472440655
- 00-1004-R/05060472440020
- 05060472442901
- 00-1007-R/05060472440013
- 05060472442918
- 00-1024-R/05060472441027
- 05060472442925
- 00-1026-R/05060472441058
- 05060472442932
Distribution
Distributed nationwide across the United States.
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