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U.S. Department of Health and Human Services

Class 2 Device Recall Centrella Smart Bed

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 Class 2 Device Recall Centrella Smart Bedsee related information
Date Initiated by FirmSeptember 18, 2024
Date PostedOctober 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0228-2025
Recall Event ID 95402
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Producta. 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.
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.
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionThe 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 Commerce2,967 beds
DistributionWorldwide distribution - US Nationwide. There was government and military distribution. The countries of Canada and Australia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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