Captus 4000e Thyroid Uptake System recalled for unexpected collimator detachment
Mirion Technologies is recalling 1,275 units of the Captus 4000e Thyroid Uptake System worldwide due to complaints of unexpected collimator detachment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall for mechanical defect (collimator detachment) in a measurement device. No injuries have been reported, but the defect poses a risk of harm to accurate device function. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Captus 4000e Thyroid Uptake System with Well, manufactured by Mirion Technologies (Capintec), Inc., is being recalled. The device is intended for thyroid uptakes, staff bioassay, and wipe tests. A total of 1,275 units have been recalled.
The recall is due to complaints of unexpected detachment of the collimator. The affected devices have been distributed worldwide, including the United States and numerous other countries. The recalled units include Model No: 5430-30152 with UDI 0859942006102 and serial numbers ranging from 940001 through 941398.
The recalled product
- Product
- Captus 4000e Thyroid Uptake System with Well. 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: 5430-30152
- UDI 0859942006102
- 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 →- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
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