Recall Z-2246-2020 ยท FNL Bed, Ac-Powered Adjustable Hospital
Hill-Rom, Inc.
Centrella Smart+ Bed, Catalog Number P7900
| Date | Apr 30, 2020 |
| Status | Terminated |
| Reason | The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit. |
| Root cause | Software design |
| Action | On April 30, 2020, the firm distributed Urgent Medial Device Correction letters to affected customers. Customers were informed that though the bed exit system will alert at the bed, it may fail to send a remote alert through the nurse call system. The firm's letter states that the risk can be immediately mitigated by changing the nurse call setting from "SideCom" to "With A.C." For detailed instructions, please see "Instructions: Changing the Nurse Call Setting" section of the letter. Customers should also complete the response form and return it to the firm. The latest software (version 1.2 |
| Quantity | 4381 beds |
| Distribution | Domestic distribution nationwide. Foreign distribution to Canada and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.