Recall Z-0177-2012
Capintec Inc · initiated July 8, 2011
Product
Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator
Codes / lots: New units with serial numbers 270439 through 270506, consecutively, and repair units with serial numbers 270210, 270196, 270014, and 270333.
Reason for recall
Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-0177-2012
- Initiated
- July 8, 2011
- Posted by FDA
- November 9, 2011
- Terminated
- December 10, 2013
- Product code
- KPT – Calibrator, Dose, Radionuclide
- Quantity
- 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.
- Recalling firm
- Capintec Inc, Pittsburgh, PA