Captus 4000e Thyroid Uptake Systems spring failure poses fall risk
Mirion Technologies recalls 467 Captus 4000e Thyroid Uptake Systems due to spring arm failure that can cause the collimator to fall, posing potential injury risk to patients and operators.
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: This FDA Class II recall involves mechanical failure creating potential injury to patients and operators. Although no injuries have been reported, the hazard (equipment falling during medical procedures) poses direct risk to user safety, meeting the rubric criterion for risk-of-harm products without reported illness.
Plain-English summary
Mirion Technologies (Capintec), Inc. is recalling 467 units of the Captus 4000e Thyroid Uptake Systems (Models 5430-30151, 5430-30152, and 5430-30154). These systems are used by trained nuclear medicine professionals to perform thyroid uptake procedures in clinical settings.
The recall is due to spring arm failure that can cause the collimator to fall to its lowest point of travel. This poses a potential injury risk to patients and healthcare operators who may be exposed to the falling equipment during procedures.
Affected devices can be identified by UDI codes 0859942006096 and 0859942006102, with serial numbers 940000 through 940535. The units were distributed nationwide and to multiple countries. Healthcare facilities should contact Mirion Technologies (Capintec), Inc. for repair, replacement, or instructions on managing their affected systems.
The recalled product
- Product
- Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- Category
- Medical Device
- Affected units
- 467
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 (1)
- UDI: 0859942006096 and 0859942006102 Serial Numbers: 940000 through 940535
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Mirion Technologies (Capintec), Inc.
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