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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89260

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

Open FDA event record

Event summary

Timeline bucket
October 12, 2021
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

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

Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000

Z-0515-2022
Recall number
Z-0515-2022
Initiated
October 12, 2021
Classification
Class II
Status
Terminated
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

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

Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

Code information

Serial Numbers: 164719 164712 164722 164723 164728 164711 164718 164703 164721 164726 164724 164725 UDI: 04056869046877

Distribution pattern

US Nationwide distribution.

device · product 2 of 3

Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600

Z-0516-2022
Recall number
Z-0516-2022
Initiated
October 12, 2021
Classification
Class II
Status
Terminated
Quantity
72 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

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

Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

Code information

Serial Numbers: 180062 180318 180054 180019 180065 180057 180041 180317 180034 180072 180349 180060 180337 180070 180048 180083 180369 180370 180345 180315 180343 180080 180301 180305 180067 180330 180040 180360 180333 180029 180352 180336 180316 180068 180363 180084 180334 180018 180350 180354 180046 180047 180335 180085 180035 180339 180357 180358 180361 180362 180081 180331 180021 180342 180321 180309 180356 180368 180341 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037 UDI: 04056869063317 Expanded Recall 12/20/21 S/N: 180056

Distribution pattern

US Nationwide distribution.

device · product 3 of 3

Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700

Z-0517-2022
Recall number
Z-0517-2022
Initiated
October 12, 2021
Classification
Class II
Status
Terminated
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

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

Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

Code information

Serial Numbers: 170319 170026 170343 170305 170307 170331 170309 170310 170023 170304 170328 170334 170336 170025 170346 170051 170333 170332 170312 170027 170303 170322 170053 UDI: 04056869149325

Distribution pattern

US Nationwide distribution.