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 3 Device Recall HoverMatt Patient Transfer Solution/Air Transfer Mattress

  • 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 3 Device Recall HoverMatt Patient Transfer Solution/Air Transfer Mattresssee related information
Date Initiated by FirmSeptember 13, 2005
Date PostedOctober 21, 2005
Recall Status1 Terminated 3 on June 07, 2006
Recall NumberZ-0084-06
Recall Event ID 33722
Product Classification Device, Patient Transfer, Powered - Product Code FRZ
ProductHoverMatt Patient Transfer Solution/Air Transfer Mattress
Code Information Model Numbers HM28HS, HM28DC, HM34HS, HM34DC, HM39HS, HM39DC
FEI Number 3001600982
Recalling Firm/
Manufacturer		 D.T. Davis Enterprises Ltd.
513 S Clewell St
Bethlehem PA 18015-4537
For Additional Information ContactWendy Weaver
610-694-9600
Manufacturer Reason
for Recall		Instructions for use are not adhering to the product
FDA Determined
Cause 2		Other
ActionRecalling firm issued recall letters dated October 5, 2005 informing the hospitals of the problem and that firm representatives would contact them to visit their facilities to affix new labels.
Quantity in Commerce866 units
DistributionProducts were shipped to hospitals nationwide. Product was also shipped to Canada, Australia, and the United Kingdom.Product was shipped to government accounts in TN, PA, and CA.
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.
-
-