a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7
Summary
The FDA issued a Class II for a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P790 by Baxter Healthcare Corporation. 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 m.
Details
Source
Device Recall
External ID
Z-0228-2025
Action Date
2024-11-06
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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.
Quantity Affected: 2,967 beds
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.
Distribution
Worldwide distribution - US Nationwide. There was government and military distribution. The countries of Canada and Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-18
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0228-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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