Z-0228-2025Class II

a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010...

Name: Z-0228-2025 a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010...
Creator: Baxter Healthcare Corporation
Published: 2024-09-18
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-09-18 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304... on 2024-09-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0228-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-18
Posted: 2024-10-25
Recalling firm: Baxter Healthcare Corporation
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.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: 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 tag: software
FDA 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 bed exit alert is silenced at the bedside first before silencing the alert at the in-room nurse call wall unit. 2. Please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 3. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them.
Quantity in commerce: 2,967 beds
Distribution: Worldwide distribution - US Nationwide. There was government and military distribution. The countries of Canada and Australia.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0228-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0228-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-25

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)