FDA Recall Terminated

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: Z-1317-2009 · Initiated March 9, 2009

Recall

Recall Number
Z-1317-2009
Event Number
51562
Firm
Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006
FEI Number
1824206
Product Code
FNL
Status
Terminated
Root Cause
Process control
Initiated
March 9, 2009
Posted
May 1, 2009
Terminated
October 13, 2010

Description

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

Reason

An e-ring may not have been installed during production, which could result in an inability to latch the siderail.

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.

Distribution

Worldwide Distribution -- USA and Canada.

Quantity

53 beds