Events

Recall of Device Recall Visum LED Surgical Lights/ Visum Halogen 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
    59866
  • Event Risk Class
    Class 2
  • Event Number
    Z-0137-2012
  • Event Initiated Date
    2011-08-23
  • Event Date Posted
    2011-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103892
  • 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
    Installation records for the switchpoint infinity, booms, lights, and flat panel systems are incomplete or inadequate.
  • Action
    Stryker sent an URGENT FIELD SAFETY NOTICE: RA2010-245 dated August 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached Customer Response Form within 5 business days to Stryker. A Stryker representative would contact them at their convenience to schedule a re-inspection for all of the units identified and still in use. In the event the inspected equipment does not meet Stryker's established specifications, their representative will visit their facility and hopefully resolve the issue. If a subsequent visit is required the date will be scheduled in full consideration of their services. For questions regarding this recall call 972-410-7310.

Device

Device Recall Visum LED Surgical Lights/ Visum Halogen Surgical Lights
  • Model / Serial
    Catalog numbers: 0682001250, 0682001251, 0682000106, and 0682000107. All product distributed and installed between July 2004 and March 2011.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including Puerto Rico, Brazil, Ecuador, Venezuela, Costa Rico, Bolivia, Peru, Mexico, China, India, Korea, Philippines, Singapore, Malaysia, Taiwan, Middle East, Russia, Africa, Poland, South Africa, Australia, New Zealand, Canada, Japan, Denmark, Finland, Norway, Sweden, Belgium, The Netherlands, France, Germany, Austria, Italy, Portugal, Spain, Romania, Switzerland, and United Kingdom.
  • Product Description
    Visum LED Surgical Lights/ Visum Halogen Surgical Lights. || Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 || Visum LED Surgical Lights and Visum Halogen Surgical Lights are ceiling mounted devices which provide illumination via LED lights and halogen bulbs. All systems are ceiling or wall mounted lights and each provides sufficient illumination with high intensity light for all types of surgical procedures.
  • 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