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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85010

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 14, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hill-Rom Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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)

Z-1554-2020
Recall number
Z-1554-2020
Initiated
February 14, 2020
Classification
Class II
Status
Terminated
Recalling firm
Hill-Rom Inc.
Quantity
35 Software Systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue which may result in failure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

NaviCare Patient Safety Software versions 3.5.400 to 3.9.300

Distribution pattern

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