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U.S. Department of Health and Human Services

Class 2 Device Recall Capintec CRC 25 PET

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  Class 2 Device Recall Capintec CRC 25 PET see related information
Date Initiated by Firm July 08, 2011
Date Posted November 09, 2011
Recall Status1 Terminated 3 on December 10, 2013
Recall Number Z-0177-2012
Recall Event ID 59425
510(K)Number K071396  
Product Classification Calibrator, dose, radionuclide - Product Code KPT
Product Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02

PET dose calibrator
Code Information New units with serial numbers 270439 through 270506, consecutively, and repair units with serial numbers 270210, 270196, 270014, and 270333.
Recalling Firm/
Capintec Inc
620 Alpha Dr
Pittsburgh PA 15238
For Additional Information Contact
Manufacturer Reason
for Recall
Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPT and Original Applicant = CAPINTEC, INC.