FDANovember 27, 2023device
Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator
What to do
FDA enforcement status: Ongoing
Brands named
mirion technologies capintecmirionmirion technologies
UPCs
08599420060960859942006102
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- 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
- FDAGE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2026-04-24
- FDAGE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2026-04-24
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