Device product
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, P7900B1SPL06, P7900B000020, P7900B100019, P7900B100039, P7900B100224, P7900B100288, P7900B000022, P7900B100020, P7900B100090, P7900B100231, P7900B100292, P7900B100001, P7900B100021, P7900B100161, P7900B100237, P7900B100293, P7900B100005, P7900B100022, P7900B100203, P7900B100242, P7900B100294, P7900B100009, P7900B100023, P7900B100205, P7900B100264, and P7900B100296. b. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900A000001, P7900A000010, P7900A000019, P7900A000039, P7900A000005, P7900A000011, P7900A000022, and P7900A000063.
Z-0228-2025
Product summary
- Event
- Event 95402
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,967 beds
- Official record key
device-enforcement:Z-0228-2025
Official wording
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.
Code information: All serial numbers with software version 1.27.000. UDI-DI 00887761985162: 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, P7900B1SPL06, P7900B000020, P7900B100019, P7900B100039, P7900B100224, P7900B100288, P7900B000022, P7900B100020, P7900B100090, P7900B100231, P7900B100292, P7900B100001, P7900B100021, P7900B100161, P7900B100237, P7900B100293, P7900B100005, P7900B100022, P7900B100203, P7900B100242, P7900B100294, P7900B100009, P7900B100023, P7900B100205, P7900B100264, and P7900B100296. UDI-DI 00887761999961: Product codes P7900A000001, P7900A000010, P7900A000019, P7900A000039, P7900A000005, P7900A000011, P7900A000022, and P7900A000063.
Distribution pattern: Worldwide distribution - US Nationwide. There was government and military distribution. The countries of Canada and Australia.
Derived failure modes
-
Unknown
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.