Events

Recall of Maquet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet Cardiovascular 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
    74915
  • Event Risk Class
    Class 2
  • Event Number
    Z-2746-2016
  • Event Initiated Date
    2016-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148768
  • 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
    Table, operating-room, ac-powered - Product Code FQO
  • Reason
    Post market surveillance cases reported to maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of maquet's connecting bracket (fixture) device is broken.
  • Action
    Maquet sent an "Urgent Product Recall Medical Device Correction Letter and Medical Device Correction Response Form" dated August 12, 2016 via UPS to their affected customers. Customers were advised to inspect all devices that include the fixture for damage before every use. Customers were asked to fill out and sign the enclosed Medical Device Correction Response Form and return it via email to FieldAction@maquet.com or fax to 1-973-909-9927. Customers with questions were advised to contact their MAQUET Representative or call MAQUET Customer Service at 1-888-627-8383. For questions regarding this recall call 973-709-7487.

Device

Maquet
  • Model / Serial
    Part Number/Catalog Number 1002.64A0
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI
  • Product Description
    The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. || The fixture is used to adapt a range of different head and horseshoe head rests with a central square mount
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Manufacturer Address
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA