Events

Recall of Device Recall Skytron Infinity Series surgical light

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Skytron, Div. The KMW Group, 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
    37120
  • Event Risk Class
    Class 2
  • Event Number
    Z-0532-2007
  • Event Initiated Date
    2007-01-08
  • Event Date Posted
    2007-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50010
  • 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
    surgical light - Product Code FTD
  • Reason
    If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
  • Action
    The firm initially notified consignees of this problem on 11/23/1999 and again on 11/01/2002 and most lights have already been corrected. Remaining consignees with lights in need of correction were notified of the problem via letter dated 1/8/07 and instructed to contact the distributor to have their lights inspected and modified.

Device

Device Recall Skytron Infinity Series surgical light
  • Model / Serial
    Each lighthead bears a unique serial number. For units with model numbers beginning with IF22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers beginning with IN22 , all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx).
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF222222-B, IF222222EL and IN222222EL.
  • Manufacturer
    Skytron, Div. The KMW Group, Inc

Manufacturer

Skytron, Div. The KMW Group, Inc
  • Manufacturer Address
    Skytron, Div. The KMW Group, Inc, 5000 36th St Se, Grand Rapids MI 49512-2008
  • Source
    USFDA