Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator
FDA device recall Z-0177-2012 · posted 2011-11-09 · Terminated
Recall details
- Recalling firm
- Capintec Inc
- Reason for recall
- Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPT
- Quantity affected
- 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.
- Date initiated
- 2011-07-08
- Date posted
- 2011-11-09
- Date terminated
- 2013-12-10
- Location
- Pittsburgh, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS (K071396) | Capintec, Inc. | 2007-06-28 |