Data Foundry

Medical device recalls 2020

NaviCare Patient Safety Software Versions 3 — Class II medical device recall Z-1554-2020

Terminated recall by Hill-Rom Inc., reported 2020-04-01, distributed in CO, GA, IN, LA, NC, NV, OR, SC…. There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.

Recall numberZ-1554-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHill-Rom Inc., Cary, NC, United States
Recall initiated2020-02-14
Classified2020-03-22
Reported by FDA2020-04-01
Terminated2021-02-11
DistributedCO, GA, IN, LA, NC, NV, OR, SC, TN, VA, WA
Quantity35 software
Reason classessoftware

Product

NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0)

Reason for recall

There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1554-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.