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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-1184-2017
Recall Event ID 75939
Product Classification Bed, therapeutic, ac-powered, adjustable home-use - Product Code LLI
Product Foot Section - BAR5490IVC
Code Information BAR5490IVC
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 292 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.