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 CLINITRON CII

  • 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 CLINITRON CII see related information
Date Initiated by Firm June 24, 2009
Date Posted August 25, 2009
Recall Status1 Terminated 3 on July 11, 2012
Recall Number Z-1902-2009
Recall Event ID 52524
510(K)Number K813584  
Product Classification Bed, air fluidized - Product Code INX
Product CLINITRON¿ CII Air Fluidized Therapy Units.

Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.
Code Information All serial numbers.
Recalling Firm/
Manufacturer		 Hill-Rom Manufacturing, Inc.
4349 Corporate Rd
Charleston SC 29405-7445
For Additional Information Contact Joe Fogel
843-740-8159
Manufacturer Reason
for Recall		 Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
FDA Determined
Cause 2		 Equipment maintenance
Action Hill-Rom issued an "Urgent Field Safety Notice" letter dated February 2, 2009 addressed to Facility Risk Managers and Facility Administrators. The notice detailed the issue and instructed users on actions to be taken. For further information, please contact Hill-Rom Customer Service at 1-800-638-2546.
Quantity in Commerce 625 units (total both units)
Distribution Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela.
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.
510(K) Database 510(K)s with Product Code = INX and Original Applicant = UHI CORP.
-
-