Centrella Smart+ Bed, Catalog Number P7900
FDA Recall Z-2246-2020 · Posted None
Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeFNL
Date Initiated2020-04-30
Date Terminated2024-01-23
Product Quantity4381 beds
Reason for Recall
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.
Firm Action
On April 30, 2020, the firm distributed Urgent Medial Device Correction letters to affected customers. Customers were informed that though the bed exit system will alert at the bed, it may fail to send a remote alert through the nurse call system.
The firm's letter states that the risk can be immediately mitigated by changing the nurse call setting from "SideCom" to "With A.C." For detailed instructions, please see "Instructions: Changing the Nurse Call Setting" section of the letter. Customers should also complete the response form and return it to the firm.
The latest software (version 1.28.000 or greater) resolves the communication issue and mitigates the potential patient risk. A software update to the latest software is required for affected devices.
Once Hill-Rom receives your response form and has confirmed that your device is affected, the firm will contact you to schedule your software update. If you have any questions or would like to proactively schedule your software update, please contact Hill-Rom Technical Support at 1-800-445-3720 (select option 2 and then select option 1) Monday through Friday, 8:00AM 5:00 PM EST.
Root Cause
Software design
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Canada and Australia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.