Z-0167-2011

Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers...

Name: Z-0167-2011 Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers...
Creator: Capintec Inc
Published: 2010-09-20
License: https://open.fda.gov/license/

Mirion Technologies (Capintec), Inc. / initiated 2010-09-20 / Terminated / root cause: manufacturing process

FDA source

Capintec Inc began a recall of Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010. Manufactured by... on 2010-09-20. The reason FDA records is "The spring arm on portable stand may have been over tightened during assembly, which may result in failure. If the spring arm fails, it will not balance the collimator weight, and the arm will drop to the lowest position". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0167-2011
Status: Terminated
Initiated: 2010-09-20
Posted: 2010-10-28
Terminated: 2012-07-05
Recalling firm: Mirion Technologies (Capintec), Inc.
Product: Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010. Manufactured by Capintec, Inc, Pittsburgh, PA.
Product code: KPT Calibrator, Dose, Radionuclide
Reason for recall: The spring arm on portable stand may have been over tightened during assembly, which may result in failure. If the spring arm fails, it will not balance the collimator weight, and the arm will drop to the lowest position.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Capintec issued an Alert letter to all customers identifying the affected device, informing them of the problem and what actions are to be taken by customers. Capintec will send a replacement arm for the system, which is to be installed by the customer using included instructions. The firm included a correction acknowledgement form to be completed and returned by the customer. Customers can contact Capintec concerning this recall at 201 825-9500.
Quantity in commerce: 9 units
Distribution: Worldwide Distribution: USA in the states of NC and TN, and in the countries of Pakistan, Paraguay, Portugal, Saudi Arabia, and Spain.
Product codes and lots: Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010

Product code KPT

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)