Recall Z-1892-2024— Mirion Technologies (Capintec), Inc.
Class II · Ongoing
Class II FDA medical device recall by Mirion Technologies (Capintec), Inc., initiated 2024-04-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.. Reason: Complaints of unexpected detachment of the collimator have been reported..
- Recalling firm
- Mirion Technologies (Capintec), Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-22
- Firm location
- Florham Park, NJ, United States
Product description
Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Reason for recall
Complaints of unexpected detachment of the collimator have been reported.
Data sourced from openFDA. This site is unofficial and independent of the FDA.