Recall Z-1069-2024— Mirion Technologies (Capintec), Inc.
Class II · Ongoing
Class II FDA medical device recall by Mirion Technologies (Capintec), Inc., initiated 2023-11-27. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator.
- Recalling firm
- Mirion Technologies (Capintec), Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-27
- Firm location
- Florham Park, NJ, United States
Product description
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
Reason for recall
Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator
Data sourced from openFDA. This site is unofficial and independent of the FDA.