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 HillRom TotalCare Bed

  • 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 HillRom TotalCare Bed see related information
Date Initiated by Firm March 09, 2009
Date Posted May 01, 2009
Recall Status1 Terminated 3 on October 13, 2010
Recall Number Z-1317-2009
Recall Event ID 51562
Product Classification Ac-Powered Adjustable Hospital Bed - Product Code FNL
Product Hill-Rom TotalCare Bed, Model P1900.

The TotalCare (R) Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare (R) Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post
Code Information Serial numbers from J329AM1149 through J339AM1343.
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006
For Additional Information Contact
800-445-3730
Manufacturer Reason
for Recall		 An e-ring may not have been installed during production, which could result in an inability to latch the siderail.
FDA Determined
Cause 2		 Process control
Action Consignees were notified by an Urgent Medical Device Correction letter dated 3/9/09 and were instructed that a Hill-Rom technician will visit each consignee to inspect and to correct the beds, if necessary. The firm asks that consignees locate and test their beds to make sure the siderails are latching correctly; forward a copy of the letter to users that were loaned or purchased the device and notify Hill-Rom of their new locations or owners; and if affected beds were disposed of or are no longer in use, to inform the firm of their serial numbers. If there are questions customers should contact their Hill-Rom Technical Support for their geographic region.
Quantity in Commerce 53 beds
Distribution Worldwide Distribution -- USA 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.
-
-