Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0177-2012 · Posted 2011-11-09

Recalling FirmCapintec Inc
Recall StatusTerminated
Product CodeKPT
Date Initiated2011-07-08
Date Terminated2013-12-10
Product Quantity69

Reason for Recall

Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071396CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORSCapintec, Inc. · 2007-06-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑