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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76712

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

Open FDA event record

Event summary

Timeline bucket
February 14, 2017
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

4 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 4

ARTISTE" MV System

Z-1488-2017
Recall number
Z-1488-2017
Initiated
February 14, 2017
Classification
Class II
Status
Terminated
Quantity
80 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software update

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

Software update

Code information

Device Model# 8139789

Distribution pattern

Distributed throughout the United States

device · product 2 of 4

Mevatron M2/Primus Mid-Energy PRIMUS HI

Z-1489-2017
Recall number
Z-1489-2017
Initiated
February 14, 2017
Classification
Class II
Status
Terminated
Quantity
80 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software update

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

Software update

Code information

Device Model# 1940035, 4504200

Distribution pattern

Distributed throughout the United States

device · product 3 of 4

ONCOR" Avant-garde

Z-1490-2017
Recall number
Z-1490-2017
Initiated
February 14, 2017
Classification
Class II
Status
Terminated
Quantity
80 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software update

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

Software update

Code information

Device Model# 1940035

Distribution pattern

Distributed throughout the United States

device · product 4 of 4

ONCOR" Expression ONCOR" Impression ONCOR" Impression plus

Z-1491-2017
Recall number
Z-1491-2017
Initiated
February 14, 2017
Classification
Class II
Status
Terminated
Quantity
80 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software update

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

Software update

Code information

Device Model# 7360717, 5857920, 5857912

Distribution pattern

Distributed throughout the United States