FDA Recalls Mirion Captus 4000e Thyroid Uptake System for Collimator Detachment
The FDA is recalling the Mirion Captus 4000e Thyroid Uptake System due to reports of unexpected collimator detachment that could affect diagnostic accuracy. Approximately 1,275 units are affected worldwide.
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 is an FDA Class II medical device recall for a system used in nuclear medicine diagnostics. The unexpected detachment of a critical collimator component poses a risk of incorrect measurements and potential patient harm from diagnostic error, but no injuries or illnesses have been reported. Per the rubric, risk-of-harm products without reported injury classify as High.
Plain-English summary
The FDA is recalling the Mirion Captus 4000e Thyroid Uptake System, a medical device used to perform thyroid uptakes, staff bioassays, and wipe tests. Approximately 1,275 units are affected by this recall.
Mirion Technologies (Capintec), Inc. initiated the recall because of complaints of unexpected detachment of the collimator, a critical component of the system that affects measurement accuracy.
The affected devices include Model 5430-30151 with serial numbers ranging from 940001 through 941398. These systems have been distributed worldwide, including throughout the United States and to customers in numerous countries including Canada, China, Japan, the United Kingdom, and others.
If you use the Captus 4000e system, contact your equipment provider or Mirion Technologies immediately to determine if your system is affected and to arrange for appropriate corrective action.
The recalled product
- Product
- Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- Hazard
- collimator-detachment
- equipment-malfunction
- diagnostic-error-risk
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: 5430-30151
- UDI 859942006096
- S/N range 940001 through 941398.
Distribution
Distributed nationwide across the United States.
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