Recall Z-0333-2011 ยท FNL Bed, Ac-Powered Adjustable Hospital
Hill-Rom, Inc.
Excel Care ES Bariatric Bed, P 610B, Hill-Rom, Batesville, IN. Intended use: The Excel Care Bariatric Bed is for bariatric patients with varying medical and physical conditions. The bed has an expandable surface and supports patients between 250 and 1000 pounds.
| Date | Nov 9, 2010 (initiated Mar 5, 2010) |
| Status | Terminated |
| Reason | The firm received complaints regarding the siderails not operating correctly or becoming inoperable. The siderails could experience false latching, unintentional lowering or become inoperable. There have been reports of 5 patient falls and 2 injuries to caregivers. |
| Root cause | Device Design |
| Action | Hill-Rom sent out "Urgent Medical Device Correction" letters dated March 5, 2010. The letters described the product, problem and actions to be taken by the customers. The letters instructed the customers to locate the beds and examine the siderails for any visible damage (cracks, bending, loose parts) and conduct a physical assessment of all four siderails on each bed to determine if the sideral could be placed in all positions. If the siderails were found to be inoperable, the bed was to be taken out of service until a qualified Hill-Rom technician can make any necessary correction. The c |
| Quantity | 1,406 beds both models. |
| Distribution | Worldwide distribution: USA states including: AK, FL, HI, IN, KS, LA, MS, OK, PA, TN, VT, and WA and countries including: Canada, Mexico, Angola, Australia, Saudi Arabia, Qatar, and United Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.