FDA Medical Device Recalls (openFDA)
Capintec Inc: Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator
- Recall number
- Z-0177-2012
- Recalling firm
- Capintec Inc
- Product
- Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator
- Status
- Terminated
- Initiated
- 2011-07-08
- Posted
- 2011-11-09
- Terminated
- 2013-12-10
- 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.
- Lot, serial or model codes
- New units with serial numbers 270439 through 270506, consecutively, and repair units with serial numbers 270210, 270196, 270014, and 270333.
- 510(k) numbers
- ["K071396"]
- PMA numbers
- not on file
- Product code
- KPT
- Firm FEI
- 2518443
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28