Mirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
Mirion Technologies is recalling 783 Captus 4000e Thyroid Uptake Systems because a tension bolt may fail, causing the spring arm to fall unexpectedly.
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: The recall involves a mechanical defect in a medical device that poses a risk of harm (falling arm) but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I/fatalities).
Plain-English summary
Mirion Technologies (Capintec), Inc. is recalling 783 units of the Captus 4000e Thyroid Uptake System, including Models 5430-30151, 5430-30152, and 5430-30154. The affected devices were shipped from April 2019 through February 2024 and have serial numbers ranging from 940548 through 941398. This recall applies to devices that have not already replaced the original arm with the redesigned arm.
The recall is due to a potential failure of the tension bolt, which could allow the spring arm to unexpectedly fall to its lowest position, approximately 25 inches (63.5 cm) from the ground. The devices were distributed worldwide, including in the United States and numerous international locations.
Healthcare facilities and users should contact Mirion Technologies for instructions on how to address the defect. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- Affected units
- 783
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 (9)
- Affected Units: Captus 4000: 1. Model 5430-30151
- UDI-DI: 00859942006096
- 2. Model 5430-30152
- UDI-DI: 00859942006102
- 3. Model 5430-30154
- UDI-DI: 00859942006423
- Devices shipped from April 2019 through February 2024
- Serial Numbers 940548 through 941398
- that have NOT already replaced the original arm with the redesigned arm.
Distribution
Distributed nationwide across the United States.
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