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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91851

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

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Event summary

Timeline bucket
April 12, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

Ultraview SL (UVSL) Command Module, Model 91496

Z-1503-2023
Recall number
Z-1503-2023
Initiated
April 12, 2023
Classification
Class II
Status
Ongoing
Quantity
1,088

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software version: 1) Older versions will

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may cause clinicians to miss a potentially catastrophic event.

Code information

Software version 2.03.06 and earlier and software version 2.04 and later.

Distribution pattern

US Nationwide distribution in the states of SD, KY, MO, WA, OH, NC, CA, OR, TX, GA, IL, OK, SC, PA, AL, KS, FL, ID, MI, MN, IA, NJ, MD, VA, AR, CT, NE, LA, AK, MS, ME, WV, NY, AZ, TN, WY, IN, MA, MT, CO, DE, ND, WI, NV, RI, NH, UT.