Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62519

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

Open FDA event record

Event summary

Timeline bucket
June 25, 2012
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

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 or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Z-2073-2012
Recall number
Z-2073-2012
Initiated
June 25, 2012
Classification
Class II
Status
Terminated
Quantity
18

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments. In a very rare scenario, the RT Therapist will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.

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

Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments. In a very rare scenario, the RT Therapist will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.

Code information

ARTISTE, Part #: 08139789, ONCOR Avant Garde, Part #: 05863472, ONCOR Impression Plus, Part #: 05857912, ONCOR Expression, Part #: 07360717

Distribution pattern

Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea.