FDANovember 5, 2018device
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.
What to do
FDA enforcement status: Terminated
Brands named
capintec
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACaptus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.2024-04-22
- FDACaptus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.2024-04-22
- FDACaptus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.2024-04-22
- FDACaptus 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 5430-301542023-11-27
- FDACaptus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.2020-03-03
- FDACaptus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-00772018-11-05
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