Mirion Technologies (Capintec), Inc. Recall 93824
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
Mirion Technologies (Capintec), Inc. Recall 93824 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1069-2024 |
| Event ID | 93824 |
| Event 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 |
| Product Type | Devices |
| Distribution | Nationwide Foreign: AUSTRIA BANGLADESH BRASIL Brazil CANADA CHILE Costa Rica Ecuador France Hanoi Vietnam Hong Kong INDIA ISRAEL ITALY Malaysia PAKISTAN Philippines POLAND Saudi Arabia SOUTH KOREA Spain SWEDEN TAIWAN THAILAND TURKEY UNITED ARAB EMIATES UNITED KINGDOM VIETNAM |
| Quantity | 467 units |
| Recall 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 |
| Device Classification | 20240221 |
| Device Code Info | UDI: 0859942006096 and 0859942006102 Serial Numbers: 940000 through 940535 |
| Center Classification Date | 20240209 |
| Recall Initiation Date | 20231127 |
| Recalling Firm | Mirion Technologies (Capintec), Inc. |
| Initial Notification | |
| Similar To |