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FDA Medical Device Recalls (openFDA)

Hill-Rom, Inc.: Hill-Rom TotalCare Bed, Model P1900. The TotalCare (R) Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare (R) Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post

Recall number
Z-1317-2009
Recalling firm
Hill-Rom, Inc.
Product
Hill-Rom TotalCare Bed, Model P1900. The TotalCare (R) Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare (R) Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post
Status
Terminated
Initiated
2009-03-09
Posted
2009-05-01
Terminated
2010-10-13
Reason
An e-ring may not have been installed during production, which could result in an inability to latch the siderail.
Root cause
Process control
Action
Consignees were notified by an Urgent Medical Device Correction letter dated 3/9/09 and were instructed that a Hill-Rom technician will visit each consignee to inspect and to correct the beds, if necessary. The firm asks that consignees locate and test their beds to make sure the siderails are latching correctly; forward a copy of the letter to users that were loaned or purchased the device and notify Hill-Rom of their new locations or owners; and if affected beds were disposed of or are no longer in use, to inform the firm of their serial numbers. If there are questions customers should contact their Hill-Rom Technical Support for their geographic region.
Quantity
53 beds
Distribution
Worldwide Distribution -- USA and Canada.
Lot, serial or model codes
Serial numbers from J329AM1149 through J339AM1343.
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

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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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