Events

Recall of Device Recall Carestream DRX1 System battery

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carestream Health, 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
    62310
  • Event Risk Class
    Class 2
  • Event Number
    Z-2202-2012
  • Event Initiated Date
    2012-06-12
  • Event Date Posted
    2012-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110191
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    Carestream drx-1 system batteries manufactured before june 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.
  • Action
    Firm sent consignees "Urgent: Customer Notification and Field Corrective Action" letters on June 8, 2012. The letters described the issue and provided recommended actions. Service dealers will contact all affected consignees to evaluate the battery. U.S. customers with questions can contact Carestream Customer Care at 800-328-2910. Customers outside the United States should contact their local Carestream service number.

Device

Device Recall Carestream DRX1 System battery
  • Model / Serial
    All DRX-1 batteries manufactured before June 2012.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, including Nationwide (USA).
  • Product Description
    Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.
  • Manufacturer
    Carestream Health, Inc.

Manufacturer

Carestream Health, Inc.
  • Manufacturer Address
    Carestream Health, Inc., 1049 Ridge Rd W, Rochester NY 14615-2731
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    USFDA