Class 2 Device Recall Bariatric Bed

• Date Initiated by Firm: December 02, 2016
• Create Date: February 09, 2017
• Recall Status: Terminated on November 02, 2017
• Recall Number: Z-1183-2017
• Recall Event ID: 75939
• Product Classification: Bed, therapeutic, ac-powered, adjustable home-use - Product Code LLI
• Product: Bariatric Bed - BARPKG-IVC 1633
• Code Information: BARPKG-IVC 1633
• Recalling Firm/ Manufacturer: Invacare Corporation; 1 Invacare Way; Elyria OH 44035-4190
• For Additional Information Contact: Janet Bonness; 440-329-6768
• 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: 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.
• 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.