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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88588

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

Open FDA event record

Event summary

Timeline bucket
August 16, 2021
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

3 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 3

syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

Z-2445-2021
Recall number
Z-2445-2021
Initiated
August 16, 2021
Classification
Class II
Status
Ongoing
Quantity
126 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

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 for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

Code information

Serial Numbers: 100713 223736 222946 223440 223032 223347 223084 223811 130643 223004 451078 101724 132011 131247 451036 132231 451032 222835 130848 500010 101773 132729 130874 133176 100421 100419 100420 100643 100642 100811 100814 100644 102369 100812 100641 100418 100813 100645 131284 130712 223734 102305 132893 223310 222411 223258 223334 223090 132781 131867 222563 222417 222491 131503 130125 451070 222224 132108 500013 132061 131169 451023 451017 451077 132701 102113 451094 130628 500007 131213 131360 500020 500028 451079 132205 451031 451001 222914 130331 451034 133191 102108 132136 131325 222686 223207 130734 102021 131578 500005 451071 222521 132904 102031 222539 222860 451039 130335 222862 222638 100677 222729 131336 223188 130452 223220 131801 131589 222719 132102 130140 223844 500004 451074 451030 133198 222601 133261 132595 130751 223150 131966 223424 223259 223058 131012 ***Updated 12/9/21*** 223021 ***Updated 1/31/22: Serial number 222475 133503

Distribution pattern

US Nationwide distribution.

device · product 2 of 3

syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670

Z-2446-2021
Recall number
Z-2446-2021
Initiated
August 16, 2021
Classification
Class II
Status
Ongoing
Quantity
44 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

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 for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

Code information

Serial Numbers: 128051 130051 128065 128035 130057 128086 128079 128041 128019 128078 128060 128068 112045 128085 128075 128022 128033 130012 128016 130044 130048 130049 128018 119216 108085 128015 130019 130055 130054 128020 128039 130052 130036 130061 128049 117756 128029 130021 130045 130039 128063 128057 128045 128046 ***UPDATED 12/9/21*** 128114 128113 130058 ***Updated 1/31/22: Serial Number 128123 130015 130081 112261 112071 128124 128132 128125 130079 130077 Expanded Recall 3/12/22: 11061620 S/N: 111805 11061660 S/N: 128144, 128135, 128142, 128136, 128133 11061670 S/N: 130088, 130094, 130090, 130087, 130091, 130092, 130089

Distribution pattern

US Nationwide distribution.

device · product 3 of 3

MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815

Z-2447-2021
Recall number
Z-2447-2021
Initiated
August 16, 2021
Classification
Class II
Status
Ongoing
Quantity
2 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

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 for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

Code information

Serial Numbers: 176302 175681

Distribution pattern

US Nationwide distribution.