Recall – Bed exit system fails to send alert

Company: Hill-Rom, Inc.
Date of Enforcement Report: 6/10/2020
Class II

PRODUCT

Centrella Smart+ Bed, Catalog Number P7900

Recall Number: Z-2246-2020

REASON

The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit.

RECALLING FIRM/MANUFACTURER

Hill-Rom, Inc. on 4/30/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

4381 beds

DISTRIBUTION

US Nationwide and International

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.