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
Recall
- Recall Number
- Z-1069-2024
- Event Number
- 93824
- Firm
- Mirion Technologies (Capintec), Inc.
- FEI Number
- 2518443
- Product Code
- IZD
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- November 27, 2023
- Posted
- February 9, 2024
- Address
- 7 Vreeland Rd, Florham Park, NJ, 07932-1511
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
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
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 arm is moved vertically, the operator and patient are not below the spring arm or in its travel path. Move the spring arm using an outstretched arm, ensuring no body parts are in the spring arm s travel path. c. Once in position, secure the arm by tightening the locking handle prior to performing Thyroid Uptake and Bioassay Procedures. d. Perform Thyroid Uptake and Bioassay Procedures with patient (or employee, for Bioassay Procedures) in a seated position, rather than a supine position on a table. e. Store the arm in an upright position. This places the least amount of stress on the internal components. Engage the locking handle when the spring arm is not being raised or lowered. If you have any questions about this Safety Alert, the Preventive Action steps outlined above, or your Captus 4000e Thyroid Uptake System, please contact Capintec Customer Support at the phone number or email listed below. If you notice any unusual change in the performance or functional response of the arm in your system (e.g. arm is making an unusual noise or arm does not move smoothly at any articulation joint), please contact Capintec Customer Support: Capintec Customer Support: 1-800-631-3826 (201) 825-9500 [email protected]
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
467 units