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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87620

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

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Event summary

Timeline bucket
March 19, 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

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

Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Z-1497-2021
Recall number
Z-1497-2021
Initiated
March 19, 2021
Classification
Class II
Status
Terminated
Quantity
133 systems

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
issue with software

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

Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.

Code information

Software VE20C serial #s 180062 170319 180317 180072 180060 180048 180083 180315 170305 180080 180301 180305 180330 170307 180040 180333 170309 170310 170304 180316 180334 170025 180047 180085 180331 180321 180309 170312 180323 164703 170303 180329 180015 180014 180037

Distribution pattern

Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL.