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
- Affected units
- 1,275
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.
Part of a larger recall action
This product is one of 3 recalled by Mirion Technologies (Capintec), Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Mirion Technologies (Capintec), Inc.
See all →- HighFDA Recalls Mirion Captus 4000e Thyroid Uptake System for Collimator Detachment
FDA (Devices) · 2024-06-05
- HighCaptus 4000e Thyroid Uptake System recalled for unexpected collimator detachment
FDA (Devices) · 2024-06-05
- HighCaptus 4000e Thyroid Uptake Systems spring failure poses fall risk
FDA (Devices) · 2024-02-21
Same hazard · equipment defect
See all →- SeverePhilips Allura Centron patient table mattress defect poses fall risk
FDA (Devices) · 2025-02-26
- HighMEDLINE Surgical Convenience Kits Recalled Due to Defective Smoke Evacuation Equipment
FDA (Devices) · 2024-12-11
- HighSurgical instrument kits recalled due to loose metal flakes
FDA (Devices) · 2024-11-20
- HighMedline Medical Convenience Kits With Defective Syringes Recalled Worldwide
FDA (Devices) · 2024-09-18
- HighMerit Medical Convenience Kits with Recalled Syringes Pose Leak Risk
FDA (Devices) · 2024-08-21