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U.S. Department of Health and Human Services

Class 2 Device Recall Bariatric Bed

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  Class 2 Device Recall Bariatric Bed see related information
Date Initiated by Firm December 02, 2016
Create Date February 09, 2017
Recall Status1 Terminated 3 on November 02, 2017
Recall Number Z-1185-2017
Recall Event ID 75939
Product Classification Bed, therapeutic, ac-powered, adjustable home-use - Product Code LLI
Product Junction Box - 1104343 and 1193560
Code Information 16FF017240 16EF024702 16EF024703 16EF022151 16EF022152 16EF022153 16EF023728 16FF017238 16FF017239 16EF024693 16EF024694 16FF019751 16EF014948 16EF018634 16EF018635 16EF018636 16FF017229 16FF017230 16EF022150 16EF032147 16EF032148 16EF032149 16EF032150 16EF032151 16EF032152 16FF015954 16FF015955 16FF015956 16FF015957 16EF018630 16EF018631 16EF034256 16EF022146 16EF022147 16EF018623 16FF017236 16EF032132 16EF027693 16EF027694 16EF029506 16EF027688 16EF027692 16EF029504 16EF024695 16FF019752 16FF019753 16EF029516 16EF029517 16EF029518 16EF029519 16EF014963 16EF024698 16EF024700 16EF024701 16FF022168 16EF016093 16EF023719 16FF022161 16FF022165 16EF024708 16FF017237 16EF027705 16EF023726 16EF014950 16EF014952 16EF011961 16EF011962 16EF011963 16EF011964 16EF014951 16EF018625 16EF018626 16EF018627 16EF018628 16EF018629 16EF022135 16EF022136 16EF022137 16EF022138 16EF022139 16FF015963 16FF015964 16FF015965 16FF015966 16FF019758 16FF019759 16FF019760 16FF019761 16FF019763 16FF019764 16FF019765 16FF019766 16FF019767 16EF023717 16EF024699 16FF022160 16EF024696 16FF022162 16FF022163 16EF022145 16EF029507 16FF017225 16EF029512 16FF017226 16EF016096 16EF016097 16EF016098 16EF029514 16EF027702 16EF016092 16EF016094 16EF016095 16EF032133 16EF037739 16EF027701 16EF027706 16EF029499 16EF032146 16EF016099 16EF016100 16EF022148 16EF022149 16EF027696 16EF034259 16EF034261 16FF019756 16EF032144 16EF029503 16EF029505 16EF029515 16FF024689 16FF024690 16EF018637 16EF018638 16EF018639 16EF018640 16EF018641 16EF018642 16EF027703 16EF027704 16EF029500 16EF029501 16EF032141 16EF032140 16EF032135 16EF037736 16EF023729 16EF023727 16FF017233 16FF017234 16EF029508 16EF029509 16FF017235 16EF018632 16EF034253 16EF034254 16EF032136 16EF032137 16EF032138 16EF032139 16EF024697 16EF027698 16EF022154 16EF027695 16EF032134 16EF024689 16EF023724 16FF022166 16FF022167 16EF018633 16EF024691 16EF024692 16FF019757 16EF027700 16FF015958 16FF015959 16FF015960 16FF015961 16FF015962 16EF022134 16EF016104 16EF016105 16EF024688 16FF019754 16FF019755 16EF029510 16EF029511 16EF034263 16EF037737 16EF027697 16EF027699 16EF027691 16EF023725 16EF034257 16EF034258 16EF024704 16EF014953 16EF014954 16EF018624 16FF017224 16EF023722 16EF023723 16EF029513 16EF034262 16EF034266 16EF032145 16EF029502 16EF016101 16EF016102 16EF014962 16EF024706 16FF022164 16EF034260 16FF017227 16FF017228 16FF017231 16FF017232 16EF016103 16EF023718 16EF034255 16EF024705 16EF037738 16EF023720 16EF027689 16EF027690 16EF032142 16EF032143 16EF034264 16EF024707 16EF024690 16EF023730 16EF034265 16EF022140 16EF022141 16EF022142 16EF022143 16EF022144 16FF022152 16FF022153 16FF022154 16FF022155 16FF022156 16FF022157 16FF022158 16FF022159 16EF014949 16EF023721 16EF027686 16EF027687 16EF018643   
Recalling Firm/
Invacare Corporation
1 Invacare Way
Elyria OH 44035-4190
For Additional Information Contact Janet Bonness
Manufacturer Reason
for Recall
A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
FDA Determined
Cause 2
Component design/selection
Action All customers were notified via letter with return receipt. This notification will include a provider letter, provider response card, impacted unit list and a consumer letter. Consignees will be instructed conduct sub-recalls as necessary. Follow-up telephone calls will be made to nonresponders.
Quantity in Commerce 161 units
Distribution Products were distributed in the following states: AK, AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. No foreign accounts
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.