Events

Recall of Device Recall ALM SURGICAL LAMPS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MAQUET 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
    51297
  • Event Risk Class
    Class 2
  • Event Number
    Z-1153-2009
  • Event Initiated Date
    2009-02-23
  • Event Date Posted
    2009-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79672
  • 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
    Lamp, surgical - Product Code FTD
  • Reason
    The screws holding the prismatic triple surgical lights may break due to dynamic multidirectional bending stress. the firm has received one complaint report.
  • Action
    An "Urgent Device Correction" letter dated February 23, 2009 was mailed by FedEx Tracking to all affected consignees. The letter described the issue, potential hazard and recommended precaution. Customers were instructed to complete the enclosed "Customer Response Fax Form" and return it via fax (1-732-667-1903) to Maquet, Inc. Maquet, Inc. will schedule repair service of the affected units once the "Customer Response Fax Form" is received. Direct questions to your local Maquet, Inc. Representative.

Device

Device Recall ALM SURGICAL LAMPS
  • Model / Serial
    Article Number: 567014999; Serial Numbers: 1104, 1105, 1106, 25163, 25340, 25341, 25890, 26012, 26417, 26418, 26686, 27251, 27753, 27854, 27855, 28096, 28097, 28813, 29652, 29950, 30087, 30152, 30333-30334, 30739, 31250, 31381, 32333, 32334, 32336, 32580, 32708, 32709 and 32800.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    ALM Prismatic Surgical Light 9551 DF; || Maquet SA. || ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.
  • Manufacturer
    MAQUET Inc.

Manufacturer

MAQUET Inc.
  • Manufacturer Address
    MAQUET Inc., 1140 US Highway 22 East, Suite 202, Bridgewater NJ 08807-2958
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA