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U.S. Department of Health and Human Services

Class 2 Device Recall Electric Powered Medical Bed

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  Class 2 Device Recall Electric Powered Medical Bed see related information
Date Initiated by Firm July 23, 2004
Date Posted November 17, 2005
Recall Status1 Terminated 3 on April 12, 2012
Recall Number Z-0158-06
Recall Event ID 29665
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product ICCG AC-Powered Adjustable Medical Bed
Code Information Model #''s:1102550, 026757, 720-3M-80PR, IH720-3MQS, IH720-3M, 720-3M-76PR, IH720-2M, IHSC900, 026746, SC900-80P, SC90080L, SC900-76L, 720FULL, IHMC2MFP76, IHMC2MF80, IHMC2MF76, IHMC2MFP76, IHMC3MFP80, IHMC3ZP4I6, IHMC2M3ZP41, IHMC23ZP236, IHMC3SP23, 1H3MRFR76, IH3MRFR80, IH3MR2076, IH3MR2080, IH3MR8FR76, IH3MF8FRU6, IH3MR8FR80, IH3MF8FRU. The serial numbers for the beds affected are as follows: 00Axxxxx thru 00Kxxxxx; 99Axxxxx thru 99Lxxxxx & 98Cxxxxx thru 98Lxxxxx.
Recalling Firm/
Manufacturer		 Invacare Corporation
1 Invacare Way
Elyria OH 44035
For Additional Information Contact Larry Smith
800-333-6900
Manufacturer Reason
for Recall		 Component Defect. Metal Oxide Varister (MOV) component of the junction box may short circuit with the potential for device failure.
FDA Determined
Cause 2		 Other
Action The manufacturer notified their distributors of the recall with telephone calls & a letter. The distributors were provided information about the recall and informed of their recall responsibilites.
Quantity in Commerce 14,343 units
Distribution World wide
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.
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