Events

Recall of Device Recall Visum LED Surgical Lights

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

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
    60812
  • Event Risk Class
    Class 2
  • Event Number
    Z-0913-2012
  • Event Initiated Date
    2011-11-07
  • Event Date Posted
    2012-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106527
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • Reason
    Stryker has identified a potential structural issue with the visum led surgical light(s). during a complaint investigation, stryker became aware that there was a possibility that incorrect assembly could result in the light head beginning to separate from the suspension arm. in the event the light separates and falls from the arm, it could lead to serious injury.
  • Action
    The firm sent "Urgent: Medical Device Correction" letters dated 11/07/2011 to their domestic and international customers. The letter informed customers of the remote risk of the light detaching from the arm and recommended continued use of the product. A representative will contact them about scheduling an appointment to inspect the lights. Contact Technical Services at 1-866-841-5663 for questions.

Device

Device Recall Visum LED Surgical Lights
  • Model / Serial
    Catalog Number: 0682001250, 0682001251, 0682001252, and 0682001253.   Product Numbers: P10235 (Visum LED Surgical Light, Camera Ready), P10234 (Visum LED Surgical Light), P12875 (Visum LED Surgical Light Camera Ready - Low Ceiling), P12874 (Visum LED Surgical Light - Low Ceiling).   Expiration date: There is no expiration date with the scope of the action. Serial Numbers: Product manufactured between October 2010 to July 2011 and in use by customer.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, and the countries of Australia, Canada, Hong Kong, Brazil, Sweden, India, Japan, Korea, Ecuador, Venezuela, Mexico, Denmark, Great Britain, and New Zealand.
  • Product Description
    Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to illuminate the operative site during surgical procedures with high intensity light.
  • Manufacturer
    Stryker Communications Corp

Manufacturer

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