Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Aquatec Fixed Backrest

  • 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 Aquatec Fixed Backrestsee related information
Date Initiated by FirmJune 25, 2014
Date PostedJuly 09, 2014
Recall Status1 Terminated 3 on April 15, 2015
Recall NumberZ-2023-2014
Recall Event ID 68399
Product Classification Chair, adjustable, mechanical - Product Code INN
ProductAquatec 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).
FEI Number 1525712
Recalling Firm/
Manufacturer		 Invacare Corporation
1200 Taylor St
Elyria OH 44035-6248
For Additional Information ContactInvacare 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
ActionThe 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 Commerce465 units
DistributionDistributed in PA and Canada.
Total Product Life CycleTPLC 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.
-
-