Recall Z-1317-2009 ยท FNL Bed, Ac-Powered Adjustable Hospital
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
| Date | May 1, 2009 (initiated Mar 9, 2009) |
| Status | Terminated |
| 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 con |
| Quantity | 53 beds |
| Distribution | Worldwide Distribution -- USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.