| | Class 2 Device Recall Electric Powered Medical Bed |  |
| 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. |
| FEI Number |
3002889431
|
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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