Events

Recall of Device Recall Capintec CRC 25 PET

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Capintec Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59425
  • Event Risk Class
    Class 2
  • Event Number
    Z-0177-2012
  • Event Initiated Date
    2011-07-08
  • Event Date Posted
    2011-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102757
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calibrator, dose, radionuclide - Product Code KPT
  • Reason
    Software error in rev. 2.01 and rev 2.02 for capintec crc 25pet.
  • 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.

Device

Device Recall Capintec CRC 25 PET
  • Model / Serial
    New units with serial numbers 270439 through 270506, consecutively, and repair units with serial numbers 270210, 270196, 270014, and 270333.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 || PET dose calibrator
  • Manufacturer
    Capintec Inc

Manufacturer

Capintec Inc