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U.S. Department of Health and Human Services

Class 2 Device Recall Aquatec Fixed Backrest

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  Class 2 Device Recall Aquatec Fixed Backrest see related information
Date Initiated by Firm June 25, 2014
Date Posted July 09, 2014
Recall Status1 Terminated 3 on April 15, 2015
Recall Number Z-2023-2014
Recall Event ID 68399
Product Classification Chair, adjustable, mechanical - Product Code INN
Product Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
Code Information Mobile Shower and Toilet commode Aquatec Ocean (Model # 1534327), Ocean VIP (Model # 1470713 and 1470793) and Ocean E-VIP (Model # 1525707).
Recalling Firm/
Manufacturer		 Invacare Corporation
1200 Taylor St
Elyria OH 44035-6248
For Additional Information Contact Invacare recall support line
440-329-6595
Manufacturer Reason
for Recall		 The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame.
FDA Determined
Cause 2		 Device Design
Action The recall notification will be sent to the two consignees informing them of the recall and to notify their customers. The letter will include a provider letter, customer letter, provider response card and impacted units listing.
Quantity in Commerce 465 units
Distribution Distributed in PA and 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.
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