Class 2 Device Recall Captus

• Date Initiated by Firm: November 27, 2023
• Date Posted: February 09, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1069-2024
• Recall Event ID: 93824
• Product Classification: Probe, uptake, nuclear - Product Code IZD
• 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
• Code Information: UDI: 0859942006096 and 0859942006102 Serial Numbers: 940000 through 940535
• Recalling Firm/ Manufacturer: Mirion Technologies (Capintec), Inc.; 7 Vreeland Rd; Florham Park NJ 07932-1511
• For Additional Information Contact: SAME; 412-963-1988
• Manufacturer 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
• FDA Determined 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 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 CapintecSupport@mirion.com
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.