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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91182

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

Open FDA event record

Event summary

Timeline bucket
November 09, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

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

ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.

Z-0472-2023
Recall number
Z-0472-2023
Initiated
November 09, 2022
Classification
Class II
Status
Ongoing
Quantity
8 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter

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

When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter

Code information

UDI: N/A S/N: 10736, 10737, 10822, 10850, 10886,10843, 10865,10025 Software version 4.3.1 MR3

Distribution pattern

US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.