The FDA announced on 2023-11-27 that Mirion Technologies (Capintec), Inc. is recalling Captus 4000e Thyroid Uptake Systems due to a spring arm failure hazard. The agency stated the defect can cause the collimator to fall, potentially injuring patients or operators.
How to tell if you have it
- Brand: Mirion Technologies
- Product: Captus 4000e Thyroid Uptake Systems
- Models: 5430-30151, 5430-30152, and 5430-30154
- UDIs: 0859942006096 and 0859942006102
- Serial Numbers: 940000 through 940535
The hazard
According to the FDA, a spring arm failure can cause the collimator to fall downward to its lowest point of travel. This defect creates a potential for injury to a patient or operator.
Context
GovInfoNow's records show Mirion Technologies (Capintec), Inc. has issued two other recalls since 2024-04-22, including a 2026-07-20 recall for tension bolt failure and a 2024-04-22 recall for collimator detachment risk. Other recent recalls of similar products include the GE Maxxus Nuclear Medicine Systems Recall (2025-12-10), the GE Medical Systems Israel SMV BodyTrack Nuclear Medicine Systems Recall (2025-12-10), and the GE Optima XR240amx Mobile X-Ray System Recall (2026-06-05).