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FDA Medical Device Recalls (openFDA)

Hill-Rom, Inc.: Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers P9964-11, P9964-12, P9964-13, P-9964-14, P9964-15, P9964-16, P9964-41 and/or P9964-42.

Recall number
Z-1777-2008
Recalling firm
Hill-Rom, Inc.
Product
Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers P9964-11, P9964-12, P9964-13, P-9964-14, P9964-15, P9964-16, P9964-41 and/or P9964-42.
Status
Terminated
Initiated
2008-04-28
Posted
2008-08-27
Terminated
2009-09-22
Reason
A risk of entrapment will exist between the head and foot rails if installation instructions are followed.
Root cause
Other
Action
Hill-Rom issued an Urgent Medical Device Correction letter on 4/28/2008 notifying consignees that they will be visited by a qualified Hill-Rom service technician or designee and provide a revised copy of the instruction sheet. The technician will either assist the facility to ensure proper installation or verify by signature that the facility understands the issue and will verify their beds had the upgrade kits installed in such a way that an entrapment gap does not exist.
Quantity
69
Distribution
Class II Recall - Nationwide Distribution --- including states of Florida, Illinois, New Mexico, Texas and Virginia.
Lot, serial or model codes
All MOD 376 HBSW Siderail Upgraded accessory kits shipped between 9/19/06 and 3/18/07. Accessory kits do not bear serial numbers.
510(k) numbers
not on file
PMA numbers
not on file
Product code
FNL
Firm FEI
1824206
Firm city
Batesville
Firm state
IN
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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