Events

Recall of Berchtold Chromophare

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

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
    77261
  • Event Risk Class
    Class 2
  • Event Number
    Z-2248-2017
  • Event Initiated Date
    2017-04-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155570
  • 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
    Device, medical examination, ac powered - Product Code KZF
  • Reason
    The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. if this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury.
  • Action
    Stryker Communications sent an Urgent Medical Device Recall letter to all affected customers. A Stryker Representative will contact their facility to schedule a service visit. to replace the adapter assembly to resolve the tolerance issue affected units. Customers with questions were instructed to Stryker Technical Support at 800-243-5135 or comm.techservice@stryker.com. For questions regarding this recall call 972-834-8656.

Device

Berchtold Chromophare
  • Model / Serial
    Serial Numbers: 7735170-X68377, 7735170-X68397, 7735170-X14846, 7735170-X15688, 7735170-X14492, 7735170-X14495, 7735170-X14497, 7735170-X14501, 7735170-X14502, 7735170-X14504, 7735170-X14506, 7735170-X14507, 7735170-X14508, 7735170-X14510, 7735170-X68383, 7735170-X68384, 7735170-X68385, 7735170-X68386, 7735170-X68393, 7735170-X68394, 7735170-X68395, 7735170-X68396, 7735170-X68392, 7735170-X68400, 7735170-X68401, 7735170-X15607, 7735170-X15608, 7735170-X15609, 7735170-X15610, 7735170-X15611, 7735170-X15612, 7735170-X15613, 7735170-X15614, 7735170-X15615
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US and Canada
  • Product Description
    Berchtold Chromophare F300 Exam Light || CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated
  • Manufacturer
    Stryker Communications

Manufacturer

Stryker Communications
  • Manufacturer Address
    Stryker Communications, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA