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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85071

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

Open FDA event record

Event summary

Timeline bucket
February 14, 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

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 Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: 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-1495-2020
Recall number
Z-1495-2020
Initiated
February 14, 2020
Classification
Class II
Status
Terminated
Quantity
1452 worldwide (638 US)

App-derived interpretation

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

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

A software issue could potentially cause the stand and table movements to be blocked.

Code information

Serial numbers: 117316 109490 117021 121396 121185 121430 117012 121406 109141 109502 109123 121336 109400 109210 121089 109080 103061 109190 109191 109197 109198 121013 117136 117324 109418 109419 109421 121040 109405 109437 109119 109346 121445 121082 109460 121459 121011 109137 109512 117108 109300 121371 109187 121134 121374 109228 109412 109066 109067 109068 121053 121054 121422 117001 117023 109133 109134 121014 121112 121209 121325 109365 109217 109366 121357 109203 121051 109496 117330 109367 121402 103258 109542 121004 121167 121378 117329 121369 117315 121133 121163 121364 109202 121018 121154 121351 121354 117125 121418 121442 121151 121036 109500 117006 109451 121205 121340 121365 121137 109526 103013 109431 109383 121078 103053 121216 103035 109015 109136 117312 109132 117018 117124 109211 109144 109413 109482 109332 121381 109536 121457 121460 121352 121421 109309 117129 109488 117112 109304 109168 109520 121434 121165 121010 109501 121171 109162 109485 109507 109038 121210 121215 109040 109457 109183 121366 103285 103286 117020 109181 121370 121391 121384 109064 109009 121472 109226 109219 117030 109321 103230 121405 109330 103277 109452 121342 121301 109414 109380 121081 109076 109435 109179 109434 121424 109424 121315 109188 117029 103001 103239 109357 109432 117123 121355 109532 109071 109072 109075 109231 109355 109503 121179 117100 121140 121416 109090 121470 121417 109311 121106 109041 121411 109164 109167 121120 117134 117307 109373 109146 121144 121383 117117 109429 121047 117111 121312 117304 117024 121027 121359 121136 103028 121175 117127 121439 121173 121462 117325 109032 109463 109415 117303 117310 109524 121419 121435 121468 109461 121008 121152 109048 121155 121160 109301 109020 109036 109043 121433 121449 109336 109480 109320 109104 121379 109361 117314 121319 117309 121058 117113 117322 109158 117014 109031 117040 121211 117041 109318 109402 121375 121377 109010 121393 121071 117114 109349 109456 121034 117009 109069 109391 109416 109189 109214 121316 109331 121440 121079 121212 109044 121046 121072 ***Added 3/30/20*** 109016 121062 109118 117034 117026 121190 109302

Distribution pattern

US Nationwide distribuiton.

device · product 2 of 3

Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: 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-1496-2020
Recall number
Z-1496-2020
Initiated
February 14, 2020
Classification
Class II
Status
Terminated
Quantity
1452 worldwide (638 US)

App-derived interpretation

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

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

A software issue could potentially cause the stand and table movements to be blocked.

Code information

Serial Numbers 123225 105120 123026 105028 111005 111122 111124 111125 123236 111002 123053 123050 123008 123035 123003 123032 123208 123209 123231 123206 123207 123240 105025 111121 123219 111115 111116 111117 111118 111119 111120 123229 123205 123224 123232 123233 123234 123027 111107 123055 123056 105017 123010 123046 111000 111106 123052 111123 111128 123200 123015 123016 105112 ***Added 3/30/2020*** 123031 123022

Distribution pattern

US Nationwide distribuiton.

device · product 3 of 3

Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: 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-1497-2020
Recall number
Z-1497-2020
Initiated
February 14, 2020
Classification
Class II
Status
Terminated
Quantity
1452 worldwide (638 US)

App-derived interpretation

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

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

A software issue could potentially cause the stand and table movements to be blocked.

Code information

Serial Numbers 154827 160851 148262 155168 154408 148299 137623 137714 125213 125238 125245 160869 147573 126202 161046 161041 154454 153834 147581 147857 147562 154532 147983 161218 160999 161032 161204 125001 161226 147604 153890 154721 154722 137193 138055 147760 147923 160449 160834 160852 138035 160944 137479 146245 160994 154567 160959 147803 125249 125241 154704 160913 148260 138087 160886 148335 154086 138112 161206 147841 155189 154727 147954 147918 160877 161008 148250 160997 147558 160864 160845 160448 138147 147955 147957 147958 160965 160800 154509 147724 138102 161236 125222 147953 137388 147553 131219 160823 147736 148215 148216 147974 154792 148298 137766 148025 160431 147972 137595 160916 137335 148282 160814 160872 146323 147992 147601 147659 147894 148010 147905 160915 125229 137421 131221 147249 153743 161021 147500 147969 148270 137119 147936 154683 160989 160501 161051 147681 147795 147845 160874 147652 161223 154653 154671 161007 154556 160862 160860 147541 147709 125223 161010 147587 154633 154020 147612 148022 160854 160429 137736 137752 138194 160149 154579 160878 148011 154560 155131 155191 125240 160856 153338 125208 125239 131223 154663 138005 160953 160903 138104 137656 138119 154592 131224 161005 160861 154684 160889 160813 161209 147668 160998 155195 137296 138015 160914 148352 147800 148254 148318 154471 148243 125210 154456 137229 147771 147944 161022 154546 161215 148278 148326 147988 147075 125201 125233 147839 161217 147655 147900 160940 148316 148273 160876 154678 148341 125214 148307 160885 155159 147287 161000 125227 125228 148207 148029 161050 124286 147717 154770 147952 148230 160825 148236 160850 155118 160942 148021 160873 161233 161234 125232 160840 147670 160956 161016 161017 147307 147718 148327 148375 154739 155150 160413 160414 160996 146705 160509 161004 160978 147301 147235 160551 148263 125244 160807 138051 161224 147937 147746 147528 147656 161235 148242 153744 ***Added 11/2/20*** 153640 146855 160493 154572 160967 147813

Distribution pattern

US Nationwide distribuiton.