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

Recall Summary Philips Tempus Pro Patient Monitors (multiple model numbers) and USB 2-Channel IBP Modules are being recalled because their measurements of intracranial pressure and bladder pressure have not been tested or validated for accuracy. Healthcare providers using these devices may make incorrect clinical decisions if they rely on these unvalidated measurements. This recall affects medical facilities using these monitoring systems.

Recalling firm

Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

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

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.

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2025-11-26

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/816f3c7e-0601-4bbf-b4b8-d9501df9629d