CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report

NaviCare Patient Safety recalled by Hill-Rom

Hill-Rom is recalling NaviCare Patient Safety, distributed in 11 states. The recall was initiated on 14 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNaviCare Patient Safety Software versions 3.5.400 to 3.9.300

Quantity recalled35 Software Systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1554-2020
FDA event ID: 85010
Recalling firm: Hill-Rom, Cary, NC
Classification: Class II
Status: Terminated
Recall initiated: 14 Feb 2020
FDA classified: 22 Mar 2020
Reported: 1 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

14 Feb 2020	Recall initiated by company
22 Mar 2020	Classified by FDA	+37 days
1 Apr 2020	Published in enforcement report	+10 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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)

Where it was distributed

Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.

Colorado Georgia Indiana Louisiana North Carolina Nevada Oregon South Carolina Tennessee Virginia Washington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

NaviCare Patient Safety Software versions 3.5.400 to 3.9.300

Where was it sold?

Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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