Recall Z-1069-2024 ยท IZD Probe, Uptake, Nuclear
Mirion Technologies (Capintec), Inc.
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
| Date | Feb 9, 2024 (initiated Nov 27, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Device Design |
| Action | Capintec issued Product Urgent Safety Alert Preventative Action letter on 11/27/23 via email. Letter states reason for recall, health risk, and action to take: 1. Review this Alert and ensure that all affected personnel, including all operators of Captus 4000e Thyroid Uptake Systems, are aware of the contents. 2. Instruct affected personnel and operators to comply with the following steps in the interest of patient and operator safety: a. Prior to moving the arm, ensure that the positioning locks are released. b. Use caution when moving the spring arm vertically. Ensure that when the spring |
| Quantity | 467 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.