| | Class 2 Device Recall Century |  |
| Date Initiated by Firm | May 20, 2005 |
| Date Posted | June 30, 2005 |
| Recall Status1 |
Terminated 3 on August 12, 2005 |
| Recall Number | Z-0948-05 |
| Recall Event ID |
32108 |
| Product Classification |
Bed, Ac-Powered Adjustable Hospital - Product Code FNL
|
| Product | Hill-Rom Century+ Bed, Model P1400. |
| Code Information |
Beds built between March 2005 and May 2005. |
| FEI Number |
1824206
|
Recalling Firm/ Manufacturer |
Hill-Rom, Inc. 125 E Pearl St Batesville IN 47006
|
| For Additional Information Contact | 800-445-3720 |
Manufacturer Reason for Recall | Sleep bed pivot bolts may break, allowing the head section to shift or to drop to one side. |
FDA Determined Cause 2 | Other |
| Action | Consignees were notified via letter dated 5/20/05 that the firm will visit consignees to make corrections to the beds. |
| Quantity in Commerce | 218 |
| Distribution | Nationwide (California, District of Columbia, Florida, Massachusetts, Montana, Nevada, New Jersey, New York, Pennsylvania, Texas, Virginia), Brazil 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.
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