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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83220

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

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Event summary

Timeline bucket
January 28, 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

Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.

Z-2035-2019
Recall number
Z-2035-2019
Initiated
January 28, 2019
Classification
Class II
Status
Terminated
Quantity
295 customer sites have the affected software versions

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.

Code information

All affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580.

Distribution pattern

Distribution was nationwide. There was also government and military distribution. Foreign distribution was made to Argentina, Bahrain, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Costa Rica, Czech Republic, France, Hong Kong, India, Indonesia, Italy, Kuwait, Malaysia, Mexico, Netherlands, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, Spain, Switzerland, Taiwan, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, and Viet Nam.

Field note

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