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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86250

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

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Event summary

Timeline bucket
August 03, 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

Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959

Z-0108-2021
Recall number
Z-0108-2021
Initiated
August 03, 2020
Classification
Class II
Status
Terminated
Quantity
124 U.S

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure

Code information

Software VD11C Patch distributed earlier via Update Instructions AX030/19/S or AX051/19/P. Serial Numbers: 103222 103285 103286 105016 109016 109021 109069 109105 109107 109158 109163 109189 109221 109300 109331 109367 109371 109393 109416 109451 109460 109504 109505 109520 111005 111104 111106 111117 111120 111123 111125 117014 117030 117117 117123 117129 117134 117303 117309 117310 117314 117325 117329 117330 121008 121058 121062 121071 121375 121377 121378 121383 121405 121417 121442 123010 123014 123023 123049 123208 123209 123233 124286 125201 125233 137245 137421 137438 137479 137729 138102 138104 138147 138156 138201 146323 147516 147612 147652 147670 147676 147724 147745 147880 147905 147923 147925 147926 147928 147944 148207 148282 148349 154532 154612 154633 154663 154739 155151 157704 158032 158458 158474 158552 160431 160449 160494 160509 160845 160850 160861 160885 160913 160942 160953 160959 160978 160999 161004 161008 161021 161050 161224 161226

Distribution pattern

US Natonwide distribution.