FDANovember 26, 2025device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
remote diagnostic technologiesremoteremote diagnostic
UPCs
05060472440624050604724406550506047244002005060472442901050604724400130506047244291805060472441027050604724429250506047244105805060472442932
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCDaikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury from Fire and Burns2026-06-25
- FDASiemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay2026-05-07
- CPSCAnalemma Water Bottles Recalled Due to Risk of Serious Injury or Death from Laceration and Ingestion Hazards; Imported by New Earth Technologies d.o.o.2026-05-07
- FDAdirectCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-22026-04-30
- FDAPhaseOne Antimicrobial Solution, Model/Catalog Number: 150502026-04-27
- FDAGE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2026-04-24
- FDAGE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2026-04-24
- FDAGE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2026-04-24
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