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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85325

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

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Event summary

Timeline bucket
August 30, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Spacelabs Healthcare, 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

Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

Z-2261-2020
Recall number
Z-2261-2020
Initiated
August 30, 2019
Classification
Class II
Status
Terminated
Quantity
2197 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.

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

The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.

Code information

Model No. 96102 Xhibit Central; Software Versions: 1.3.1, 1.3.2, 1.3.3 and 1.3.4; UDI: 10841522100345

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.