Hospital Bed Fails to Send Remote Alerts Through Nurse Call System
Hillrom Centrella Smart+ hospital beds may fail to send remote alerts through the Rauland Responder 5 Nurse Call System, though local bed alerts still function. This could delay nursing staff notification of patient needs.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a risk-of-harm product where no illnesses or injuries have been reported. The potential failure to send remote alerts through a nurse call system represents a meaningful patient safety risk in a hospital care environment.
Plain-English summary
Hillrom Centrella Smart+ hospital beds distributed worldwide are subject to an interface issue with the Rauland Responder 5 Nurse Call System. The beds have the potential to alert at the bed itself, but may fail to send a remote alert through the nurse call system to notify staff elsewhere.
This issue affects 2,967 beds manufactured by Baxter Healthcare Corporation with software version 1.27.000. The affected beds have been distributed nationwide in the United States as well as internationally to Canada and Australia, including government and military facilities.
The primary bed-side alert will still function, but the failure to send remote alerts through the nurse call system could delay staff notification of bed exit alerts and other patient-related events. This represents a risk to patient safety, as delayed staff response to bed alerts could result in harm.
Healthcare facilities should verify their system configuration and test the integration between their Centrella Smart+ beds and their Rauland Responder 5 system to ensure remote alerts are functioning properly. Contact Hillrom and the FDA for remediation options and additional guidance.
The recalled product
- 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, P7900B10
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- communication-failure
- missed-remote-alert
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- P7900B100010
- P7900B100024
- P7900B100208
- P7900B100273
- P7900B100304
- P7900B000005
- P7900B100011
- P7900B100025
- P7900B100212
- P7900B100277
- P7900B100307
- P7900B000010
- P7900B100017
- P7900B100026
- P7900B100222
- P7900B100281
- P7900B1SPL05
- P7900B000011
- P7900B100018
- P7900B100028
Distribution
Distributed nationwide across the United States.
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