Events

Recall of Device Recall ALM X TEN

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GETINGE US SALES LLC.

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
    79340
  • Event Risk Class
    Class 2
  • Event Number
    Z-1927-2018
  • Event Initiated Date
    2017-11-16
  • Event Date Posted
    2018-03-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162071
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Surgical Lights - Product Code N/A
  • Reason
    Getinge has received complaints concerning the x ten surgical lights whose spring arms have broken, causing light heads to separate from the assembly. the issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.
  • Action
    Maquet/Getinge notified customers via an Urgent Medical Device Recall Notice dated November 16, 2017.

Device

Device Recall ALM X TEN
  • Model / Serial
    Serial Nos. ON000104-ON098394
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. and Gov. accts.
  • Product Description
    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
  • Manufacturer
    GETINGE US SALES LLC

Manufacturer

GETINGE US SALES LLC
  • Manufacturer Address
    GETINGE US SALES LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA