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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83255

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 20, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA, 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

2 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 2

Cios Alpha VA20/ VA30 mobile X-Ray systems

Z-1953-2019
Recall number
Z-1953-2019
Initiated
June 20, 2019
Classification
Class II
Status
Terminated
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DAP chamber may be missing an insulating foil

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DAP chamber may be missing an insulating foil

Code information

Material # 10308191 Serial # 13161

Distribution pattern

IL, NE

device · product 2 of 2

Cios care fusion system

Z-1954-2019
Recall number
Z-1954-2019
Initiated
June 20, 2019
Classification
Class II
Status
Terminated
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DAP chamber may be missing an insulating foil

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DAP chamber may be missing an insulating foil

Code information

material # 10308192 Serial # 31375

Distribution pattern

IL, NE