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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86185

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

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Event summary

Timeline bucket
August 19, 2020
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

Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

Z-3005-2020
Recall number
Z-3005-2020
Initiated
August 19, 2020
Classification
Class II
Status
Terminated
Quantity
64 systems US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

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Inspect official wording and provenance

Reason for recall

Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location

Code information

Serial Numbers: 100418 100419 100420 100421 100641 100642 100643 100644 100645 100704 100713 100735 100811 100812 100813 100814 101724 102013 102031 102108 102305 102369 130125 130140 130331 130335 130628 130751 130848 130874 131012 131169 131247 131284 131325 131336 131360 131503 131578 131589 131801 131966 132011 132061 132102 132108 132136 132231 132595 132729 222224 222411 222417 222475 222491 222539 222563 222601 222638 222686 222946 223004 223084 451001

Distribution pattern

US Nationwide distribution.