The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2246-2020·Announced 2020-06-10

Hill-Rom Centrella Smart+ Bed Recall for Alert System Failure

Hill-Rom is recalling 4,381 Centrella Smart+ Beds because the Bed Exit System may fail to send remote alerts to the nurse call system under specific conditions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall is classified as FDA Class II, and the hazard involves a failure of a safety alert system in a medical device, which poses a risk of harm without reported injuries.

Plain-English summary

Hill-Rom, Inc. is recalling 4,381 Centrella Smart+ Beds (Catalog Number P7900) due to a defect in the Bed Exit System. The system may fail to send a remote alert through the nurse call system if a previous remote alert was sent and then cancelled at the in-room nurse call wall unit.

The affected beds were distributed domestically across the United States, as well as to Canada and Australia. The recall covers specific serial codes manufactured between U290PF8145 and V015PF2473, along with additional serial codes that were updated during servicing.

Hill-Rom is the recalling firm. The source text does not specify the corrective action or instructions for consumers or healthcare facilities.

The recalled product

Product
Centrella Smart+ Bed, Catalog Number P7900
Manufacturer
Hill-Rom, Inc.
Affected units
4,381

Distribution

Distributed nationwide across the United States.

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