Recall Z-1864-2012 ยท FNL Bed, Ac-Powered Adjustable Hospital
Hill-Rom, Inc.
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
| Date | Jun 22, 2012 (initiated Jun 18, 2012) |
| Status | Terminated |
| Reason | During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail. |
| Root cause | Process design |
| Action | Hill-Rom sent an "URGENT FIELD SAFETY NOTICE" dated May 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included a Customer Response Form for customers to complete and return to the firm. Contact Hill-Rom Technical Support at 800-445-3720 for questions regarding this notice. |
| Quantity | 7843 devices |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.