Recall Z-0177-2012 ยท KPT Calibrator, Dose, Radionuclide
Capintec Inc
Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator
| Date | Nov 9, 2011 (initiated Jul 8, 2011) |
| Status | Terminated |
| Reason | Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS Capintec, Inc., Jun 28, 2007 |