Recall Z-0228-2025 ยท FNL Bed, Ac-Powered Adjustable Hospital
Baxter Healthcare Corporation
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B100026, P7900B100222, P7900B100281, P7900B1SPL05, P7900B000011, P7900B100018, P7900B100028, P7900B100223, P7900B100287, P7
| Date | Oct 25, 2024 (initiated Sep 18, 2024) |
| Status | Open, Classified |
| Reason | The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system. |
| Root cause | Software design |
| Action | The recalling firm issued letters on and dated 9/18/2024 via first class mail. The letter informed the consignee of the issue, the beds involved, and that Baxter will be upgrading the software on all Centrella Smart+ beds with the affected software version to resolve the issue. An Attachment was enclosed listing the affected product codes for the beds. The hazard involved and the actions to be taken by customers were provided, which included: 1. To mitigate the patient risk associated with this software issue, customers using the Rauland Responder 5 Nurse Call system should ensure the be |
| Quantity | 2,967 beds |
| Distribution | Worldwide distribution - US Nationwide. There was government and military distribution. The countries of Canada and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.