Z-0177-2012

Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator

Name: Z-0177-2012 Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator
Creator: Capintec Inc
Published: 2011-07-08
License: https://open.fda.gov/license/

Mirion Technologies (Capintec), Inc. / initiated 2011-07-08 / Terminated / root cause: software

FDA source

Capintec Inc began a recall of Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator on 2011-07-08. The reason FDA records is "Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0177-2012
Status: Terminated
Initiated: 2011-07-08
Posted: 2011-11-09
Terminated: 2013-12-10
Recalling firm: Mirion Technologies (Capintec), Inc.
Product: Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator
Product code: KPT Calibrator, Dose, Radionuclide
Reason for recall: Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET
Root cause tag: software
FDA root cause: Software design
Action: Capintec, Inc. sent a Software Error Alert letter dated July 8, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contac their Capintec Customer Support Representative to receive a software upgrade. For questions call Capintec Customer Support at 1-800-631-3826.
Quantity in commerce: 69
Distribution: Worldwide distribution - United States including CA, FL, IL, MA, NJ, OK, PA, and VA; and internationally to Brazil, China, India, Indonesia, Italy, Japan, Korea, South Korea, and Turkey.
Product codes and lots: New units with serial numbers 270439 through 270506, consecutively, and repair units with serial numbers 270210, 270196, 270014, and 270333.

Product code KPT

K071396Class IICrc 25 Series (Crc 25R, Crc 25Pet, Crc 25W) Dose CalibratorsCapintec, Inc. / cleared 2007-06-28

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)