Mirion Captus 4000e Thyroid Uptake System Recalled for Collimator Detachment
Mirion Technologies is recalling the Captus 4000e Thyroid Uptake System due to complaints of unexpected collimator detachment. Affected users should contact the manufacturer for guidance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall addresses an unexpected collimator detachment in a medical diagnostic device. Complaints of the defect have been reported, but no injuries or hospitalizations are documented, meeting the criterion for High severity as a risk-of-harm product without reported injury.
Plain-English summary
The Captus 4000e Thyroid Uptake System, manufactured by Mirion Technologies (Capintec), Inc., is being recalled due to complaints of unexpected detachment of the collimator. The system is used to perform thyroid uptakes, staff bioassay, and wipe tests.
The recall affects 1,275 units with Model No. 5430-30154 and serial numbers ranging from 940001 through 941398. These units have been distributed worldwide, including throughout the United States and in more than 35 countries.
If you operate a Captus 4000e system, contact Mirion Technologies immediately for instructions. Do not use the equipment until you have verified it is not affected and have received guidance from the manufacturer.
The recalled product
- Product
- Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- Hazard
- equipment-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: Model No: 5430-30154
- UDI 0859942006423
- S/N range 940001 through 941398.
Distribution
Distributed nationwide across the United States.
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