Date Initiated by Firm |
April 11, 2000 |
Date Posted |
April 18, 2003 |
Recall Status1 |
Terminated 3 on December 16, 2003 |
Recall Number |
Z-0748-03 |
Recall Event ID |
25452 |
Product Classification |
Bed, Flotation Therapy, Powered - Product Code IOQ
|
Product |
TriaDyne I and TriaDyne II Powered Adjustable Hospital Beds |
Code Information |
All Serial Numbers |
Recalling Firm/ Manufacturer |
Kinetic Concepts, Inc 4958 Stout Drive San Antonio TX 78219
|
Manufacturer Reason for Recall |
Battery Failure/ Outgassing
|
FDA Determined Cause 2 |
Other |
Action |
Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002. |
Quantity in Commerce |
915 units |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC Device Report
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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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