Events

Recall of Device Recall GSeries

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invacare Corporation.

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
    69450
  • Event Risk Class
    Class 2
  • Event Number
    Z-1036-2015
  • Event Initiated Date
    2014-12-05
  • Event Date Posted
    2015-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130701
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Reason
    Invacare identified that the rail mounting bracket on the g29 full length bed rail was out of specification for entrapment safety.
  • Action
    Invacare sent an Urgent Medical Device Recall letter dated December 5, 2014, to all affected customers. The letter identified the product and the problem. Customers with questions should call 440-329-7996. For questions regarding this recall call 440-329-6875.

Device

Device Recall GSeries
  • Model / Serial
    Model G5510 Date codes:  40121 40122 40130 40131 40201 40204 40205 40206 40210 40211 40212 40213 40214 40217 40218 40219 40220 40221 40224 40225 40226 40227 40228 40303 40304 40305 40306 40307 40310 40311 40312 40313 40314 40319 40325 40326 40327 40331 40401 40402 40403 40404 40410 40411 40414 40415 40416 40421 40422 40423 40424 40425 40429 40429 40430 40501 40502 40506 40507 40508 40512 40513 40514 40515 40516 40519 40520 40521 40522 40523 40526 40527 40528 40529 40530 40603 40604 40605 40606 40610 40611 40612 40613 40616 40617 40618 40619 40620 40623 40624 40625 40626 40627 40630 40701 40702 40703 40707 40708 40709 40714 40715 40716 40717 40721 40722 40723 40724 40728 40729 40730 40731 40805 40806 40807 40811 40812 40813 40818 40819 40820 40825 40826 40901 40902 40904
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including OH, CO, MO, and NY.
  • Product Description
    G- Series Beds; G29 full length bed rails assembly
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA