FDAMay 25, 2021device
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
What to do
FDA enforcement status: Ongoing
Brands named
remote diagnostic technologiesremoteremote diagnostic
UPCs
05060472441058989706000101
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- 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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