Recall Z-1317-2009
Hill-Rom, Inc. · initiated March 9, 2009
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
Codes / lots: Serial numbers from J329AM1149 through J339AM1343.
Reason for recall
An e-ring may not have been installed during production, which could result in an inability to latch the siderail.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1317-2009
- Initiated
- March 9, 2009
- Posted by FDA
- May 1, 2009
- Terminated
- October 13, 2010
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Quantity
- 53 beds
- Distribution
- Worldwide Distribution -- USA and Canada.
- Recalling firm
- Hill-Rom, Inc., Batesville, IN