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Captus 4000e Thyroid Uptake Systems- Intended to be used by… recallZ-1069-2024 · Mirion Technologies (Capintec), Inc. · initiated Nov 27, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Mirion Technologies (Capintec), Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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]

Recall details

Recall number
Z-1069-2024
Status
Open, Classified
Initiated by the company
Nov 27, 2023
Posted by the FDA
Feb 9, 2024
Recalling firm
Mirion Technologies (Capintec), Inc.
Quantity
467 units
Product code
IZD
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

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

Code information (models, lots, serial numbers)

UDI: 0859942006096 and 0859942006102 Serial Numbers: 940000 through 940535

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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