Date Initiated by Firm | December 26, 2003 |
Date Posted | January 10, 2004 |
Recall Status1 |
Terminated 3 on May 13, 2004 |
Recall Number | Z-0338-04 |
Recall Event ID |
28009 |
Product Classification |
Bed, Ac-Powered Adjustable Hospital - Product Code FNL
|
Product | Hill-Rom brand Century+ bed; model P1400. |
Code Information |
All beds distributed between August 3, 2003 and August 20, 2003. |
Recalling Firm/ Manufacturer |
Hill-Rom, Inc. 125 E Pearl St Batesville IN 47006
|
For Additional Information Contact | 800-445-3720 |
Manufacturer Reason for Recall | If fluid is spilled on the siderail or the bed control areas, the bed may change positions without user input. |
FDA Determined Cause 2 | Other |
Action | A recall letter dated December 26, 2003 was sent to each customer. Customers are asked to follow instructions in the user manual, if there is a fluid spill onto a unit, until Hill-Rom can inspect each unit to determine whether it is affected by the problem. |
Quantity in Commerce | 222 |
Distribution | United States, Canada , Panama and Taiwan. |
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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