Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1317-2009

Hill-Rom TotalCare Bed, Model P1900. The TotalCare (R) Bed System is intended to provide a patient support...

Hill-Rom Inc. / initiated 2009-03-09 / Terminated / root cause: manufacturing process

Hill-Rom, Inc. began a recall of 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... on . The reason FDA records is "An e-ring may not have been installed during production, which could result in an inability to latch the siderail". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1317-2009
Status
Terminated
Initiated
Posted
Terminated
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
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
An e-ring may not have been installed during production, which could result in an inability to latch the siderail.
Root cause tag
manufacturing process
FDA 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 in commerce
53 beds
Distribution
Worldwide Distribution -- USA and Canada.
Product codes and lots
Serial numbers from J329AM1149 through J339AM1343.