• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Invacare Foot Section for Semi & Full Electric Beds, Junction Boxes

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Invacare Foot Section for Semi & Full Electric Beds, Junction Boxes see related information
Date Initiated by Firm March 15, 2016
Create Date August 11, 2016
Recall Status1 Terminated 3 on September 15, 2017
Recall Number Z-2401-2016
Recall Event ID 73577
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes,

Product Usage:
The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
Code Information Model #: BAR5490IVC; Serial #s: 15BF023716 15CF008150 15JF012488 15JF012489 15JF012490 15BF048545 15BF039458 15BF039459 15BF039460 15BF039461 15BF039462 15BF039463 15BF039464 15BF039465 15BF039466 15BF039467 15BF045955 15BF045956 15CF020336 15CF020337 15CF020338 15CF020339 15CF020340 15CF020341 15CF037863 15DF027823 15DF027824 15DF027825 15DF027826 15DF027827 15DF042103 15DF042105 15DF046695 15EF007464 15EF013525 15EF014826 15EF014827 15EF014828 15GF006921 15GF006925 15GF013384 15GF013385 15GF013386 15GF030883 15GF030885 15GF033318 15HF027020 15HF034771 15HF034775 15HF043300 15HF043301 15IF020130 15IF020131 15IF028759 15IF028760 15IF028761 15IF028762 15IF028763 15IF028764 15IF044966 15IF044967 15IF044968 15IF044969 15KF014068 15KF018077 15LF011111 15LF011112 15LF011113 15LF011114 15LF011115 15LF013140 16AF003847 16AF009018 16AF026282 16AF026283 16AF026284 16AF026285 16AF026286 16AF044630 16BF020098 16BF024626 15AF016197 15AF016198 15BF007602 15AF051670 15BF000847 15AF048735 15AF048736 15AF048737 15AF048738 15AF048739 15AF051666 15BF000861 15CF055428 15DF027818 15AF034671 15BF004206 15BF007603 15FF022340 15AF051103 15LF013148 15LF025830 15BF010331 15BF012341 15BF012342 14LF046072 15AF051112 15GF027655 15AF051095 15AF048745 15DF027837 15DF013439 15AF048750 15BF034208 15IF033597 15DF011339 15IF033598 15IF033599 15AF048746 15AF051113 15CF024425 15BF034211 15EF005745 15AF034667 15BF000846 15BF035731 15EF025673 15BF000856 16AF003844 15EF018852 16AF018116 16AF018117 15IF026982 15AF051667 15AF051668 15BF023707 15BF034202 15GF000934 15AF051660 15CF003032 15CF003033 15FF000659 15HF010984 15HF010985 15HF010986 15HF010987 15GF035697 15JF007592 15LF016363 15CF020342 15CF020343 15CF020344 15CF020345 15CF020346 15CF020347 15BF048546 15BF048547 15BF048548 15AF048743 15FF022349 15FF022350 15FF029234 15FF029235 16AF037634 15BF004207 15BF023702 15BF023704 15IF020133 15BF000843 16BF000459 16AF024506 15AF048740 15AF051110 15AF051662 15AF051664 15AF051671 15AF051672 15AF051673 15AF051675 15AF051676 15BF000844 15BF004196 15BF004200 15BF012363 15BF012367 15BF023708 15BF023714 15BF034209 15BF034210 15BF034212 15BF045954 15BF045957 15BF045961 15BF048544 15BF054034 15CF008151 15CF013305 15CF035104 15CF048595 15DF011360 15DF011361 15DF011362 15DF013435 15DF013436 15DF022423 15DF031016 15DF031024 15DF036938 15DF036942 15DF038246 15DF044092 15DF044093 15EF009576 15EF012102 15EF012113 15FF000635 15FF026854 15FF026855 15FF042135 15GF025792 15GF027657 15GF027658 15HF012654 15HF012713 15HF012714 15HF012730 15HF027021 15HF027022 15HF034774 15HF040889 15HF040890 15HF043299 15HF043302 15IF000649 15IF001675 15IF008402 15IF012421 15IF012429 15IF012432 15IF024194 15IF026997 15IF027007 15IF033596 15JF001227 15JF001228 15JF001231 15JF016390 15JF025952 15JF025953 15JF027532 15JF030831 15KF012548 15KF034633 15LF023491 15LF023492 15LF025834 16AF024514 16AF024515 15AF051658 15AF048744 15BF000848 15BF023713 15JF019602 15JF035238 15GF013366 15GF013367 15GF013420 15IF044956 15AF016194 15AF051115 15BF045958 15AF051108 15CF024427 15HF000358 15BF042552 15BF048559 15KF022097 15KF022112 15KF022113 15LF032416 15AF009531 15FF000668 15HF012643 15AF022202 15AF022206 15FF037335 15FF037336 15AF051663 15EF018851 15JF014678 15AF016195 15DF003896 15EF001710 15LF030498 15AF048751 15BF000855 15BF000850 15IF008400 15AF051118 15AF051119 15BF034200 15BF039474 15BF039475 15BF039476 15BF039477 15CF013304 15CF013306 15AF016196 15FF042134 15KF001133 16AF018111 15FF022343 15FF022344 15GF030884 15AF051677 15GF006871 15IF003784 16AF016786 16AF016790 15AF051659 15BF045962 15BF045963 15BF051635 15IF022370 15AF048754 15AF048747 15BF000859 15BF000860 15JF036138 15BF007601 15AF009530 15BF000862 15AF051116 15AF051117 15AF051111 15AF051665 15AF051669 15AF051109 15AF048753 16BF000446 16AF005412 15BF000845 15CF008152 15CF008153 15HF041620 15AF051114 15HF027023 15BF000849 15AF048748 15CF040155 15AF048742 15IF033595 15AF048749 15BF042564 15DF009682 15DF038237 15DF038238 15DF038242 15JF012492 15KF018086 15AF051674 15AF048752 15JF035252 15JF035253 15JF035254 15JF035255 15AF051104 15AF051105 15AF051106 15AF051107 15AF051661 15BF000838 15BF000839 15BF000840 15BF000841 15BF000842 15KF003936 15KF003937 15KF003938 15KF003939 15KF003940 15BF004210 15AF034669 15AF048741 15KF006390 15KF006391
Recalling Firm/
Invacare Corporation
1200 Taylor St
Elyria OH 44035-6248
For Additional Information Contact
Manufacturer Reason
for Recall
The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Invacare sent an Urgent Medical Device Recall letter dated May 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call Invacares recall support line at (877) 413-6008, Monday  Friday, 8 a.m.  5 p.m. EST, for assistance.
Quantity in Commerce 3,050 units
Distribution US Nationwide Distribution including DC and PR. Internationally Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.