Z-1069-2024Class II

Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear...

Name: Z-1069-2024 Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear...
Creator: Mirion Technologies (Capintec), Inc.
Published: 2023-11-27
License: https://open.fda.gov/license/

Mirion Technologies (Capintec), Inc. / initiated 2023-11-27 / Open, Classified / root cause: design

FDA source

Mirion Technologies (Capintec), Inc. began a recall of Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake... on 2023-11-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1069-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-27
Posted: 2024-02-09
Recalling firm: Mirion Technologies (Capintec), Inc.
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
Product code: IZD Probe, Uptake, Nuclear
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
Root cause tag: design
FDA 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 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]
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
Product codes and lots: UDI: 0859942006096 and 0859942006102 Serial Numbers: 940000 through 940535

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1069-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1069-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09

Product code IZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)