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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83082

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

Open FDA event record

Event summary

Timeline bucket
June 06, 2019
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

12 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 12

Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135

Z-1894-2019
Recall number
Z-1894-2019
Initiated
June 06, 2019
Classification
Class II
Status
Terminated
Quantity
63

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Code information

Serial Numbers: 135954 136032 136077 136043 136190 136197 136168 136143 136234 136383 136242 136393 136128 136147 136350 136256 136314 136548 136550 136557 136558 137165 137119 136607 137388 137231 137471 137591 137245 137369 137347 137329 137391 137479 137425 124006 138061 137461 137518 137567 137582 137667 137595 137656 138104 138190 124116 137714 124119 138012 138070 138017 138058 138194 138156 138214 138128 138180 138188 138260 138268 138311 138259

Distribution pattern

Nationwide

device · product 2 of 12

Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137

Z-1895-2019
Recall number
Z-1895-2019
Initiated
June 06, 2019
Classification
Class II
Status
Terminated
Quantity
276

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Code information

Serial Numbers: 147208 146637 146395 146728 146942 146697 146663 146731 146945 146774 146784 146866 147186 146867 146692 146869 146759 146776 146775 146797 146871 146801 146857 146803 146886 146758 146806 146851 146929 147157 146971 146919 146969 146973 146925 147695 146948 146964 147046 146861 147123 146883 147216 147866 146888 146955 147214 146921 147931 147100 146928 146946 147030 146983 146899 147089 146975 146963 146986 146960 146898 146937 146918 147047 146977 146993 147035 146982 147075 147084 146991 147114 147023 147233 147049 147036 147093 147009 147500 146996 147029 147174 147766 147113 147241 147083 147087 147124 147120 147119 147172 147692 147693 147775 147165 147167 147303 147079 147203 147107 147168 147144 147237 147240 147236 147239 147243 147234 147190 147175 147515 147559 147250 147254 147253 147252 147251 147649 147612 147557 147507 147516 147585 147528 147573 147264 147620 147558 147526 147604 147646 147581 147608 147849 147583 147553 147601 147659 147644 147701 147666 147635 147625 147905 147660 147842 147577 147587 147621 147670 147700 147662 147718 147737 147887 147676 147717 147783 147709 147364 125111 147734 147753 147893 147763 147956 147958 147957 147373 147955 147749 147760 147761 147821 147889 147847 147833 125003 147773 147800 147838 147816 147862 147921 147795 147926 147928 147925 147940 147880 147841 148274 147938 147891 148282 148242 148240 148239 125230 147894 147909 147882 148327 147896 147937 147892 147919 147910 147982 147923 147936 147954 147934 147952 147983 147992 125008 148375 147974 125010 125105 125106 125109 125100 148001 147977 148010 148230 125112 148022 148020 148235 148220 148029 148278 148025 148030 148285 125239 125208 125219 125212 148254 148318 148335 125115 125214 148352 148341 148326 125228 125227 125222 125210 125250 125226 125245 125254 148348 148316 125243 125240 148333 125244 125235 125232 148409 148407 148349 148384 148404 148382 148400 125253 125249 148423

Distribution pattern

Nationwide

device · product 3 of 12

Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141

Z-1896-2019
Recall number
Z-1896-2019
Initiated
June 06, 2019
Classification
Class II
Status
Terminated
Quantity
120

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Code information

Serial Numbers: 153883 154041 153640 153772 154007 153870 153762 153700 153797 153827 153898 153779 153869 153952 153736 153829 153763 153998 153819 153758 153928 153760 153865 153903 153908 154592 153863 154785 154079 153988 153882 153831 153939 153875 153847 153930 153913 153890 153922 153992 153916 153975 154012 153947 154076 154086 154058 154028 154073 154048 154034 153987 154093 154090 154074 154052 154075 154406 154408 154459 154425 154423 154502 154084 154579 154546 154085 154471 154453 154097 154098 154544 154663 154576 154572 154560 154584 154571 154096 154514 154556 154509 154731 154536 154564 154739 154596 155147 154783 154653 154732 154687 154685 154779 154708 155150 154709 154715 154789 131011 131224 154800 131013 155119 131101 154814 131105 155122 131108 131110 155126 155131 155148 155189 131223 155195 131219 155203 155235 131231

Distribution pattern

Nationwide

device · product 4 of 12

Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959

Z-1897-2019
Recall number
Z-1897-2019
Initiated
June 06, 2019
Classification
Class II
Status
Terminated
Quantity
29

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Code information

Serial Numbers: 160335 160430 160368 160469 160357 160370 160369 160509 160427 160433 160443 160428 160429 160463 160001 160461 160486 160800 160487 160488 160507 160840 160862 160856 160823 160914 160930 161235 160401

Distribution pattern

Nationwide

device · product 5 of 12

Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280

Z-1898-2019
Recall number
Z-1898-2019
Initiated
June 06, 2019
Classification
Class II
Status
Terminated
Quantity
12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Code information

Serial Numbers: 103008 103030 103028 103258 103221 103222 103277 103220 103279 103285 103286 103295

Distribution pattern

Nationwide

device · product 6 of 12

Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281

Z-1899-2019
Recall number
Z-1899-2019
Initiated
June 06, 2019
Classification
Class II
Status
Terminated
Quantity
131

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Code information

Serial Numbers: 109007 109057 109028 109027 109011 109021 109009 109010 109072 109075 109071 109041 109039 109032 109020 109036 109048 109088 109101 109040 109034 109031 109043 109067 109068 109093 109080 109179 109134 109133 109496 109076 109105 109104 109107 109084 109060 109164 109167 109135 109119 109090 109096 109091 109146 109102 109092 109189 109129 109143 109183 109606 109144 109171 109155 109217 109159 109172 109211 109169 109229 109166 109388 109350 109332 109210 109309 109203 109369 109300 109202 109401 109302 109346 109429 109214 109301 109311 109320 109330 109349 109373 109361 109231 109379 109331 109432 109434 109324 109417 109327 109344 109367 109435 109352 109380 109515 109461 109386 109365 109415 109366 109412 109383 109493 109518 109445 109437 109558 109526 109458 109424 109456 109451 109463 109467 109598 109484 109536 109538 109500 109501 109592 109527 109569 109627 109599 109591 109613 109610 109628

Distribution pattern

Nationwide

device · product 7 of 12

Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

Z-1900-2019
Recall number
Z-1900-2019
Initiated
June 06, 2019
Classification
Class II
Status
Terminated
Quantity
73

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Code information

Serial Numbers: 121013 121057 121056 121058 121006 121185 121016 121027 121020 121321 121448 121040 121049 121015 121094 121082 121089 121383 121144 121319 121137 121085 121155 121193 121136 121165 121140 121141 121151 121168 121169 121154 121211 121188 121415 121183 121209 121187 121309 121200 121313 121206 121361 121366 121359 121393 121301 121407 121406 121352 121379 121364 121342 121471 121520 121411 121412 121402 121430 121502 121421 121472 121460 121457 121515 121444 121516 121510 121491 121525 121530 121527

Distribution pattern

Nationwide

device · product 8 of 12

Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283

Z-1901-2019
Recall number
Z-1901-2019
Initiated
June 06, 2019
Classification
Class II
Status
Terminated
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Code information

Serial Numbers: 117309 117125

Distribution pattern

Nationwide

device · product 9 of 12

Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353

Z-1902-2019
Recall number
Z-1902-2019
Initiated
June 06, 2019
Classification
Class II
Status
Terminated
Quantity
8

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Code information

Serial Numbers: 105018 105016 105032 105124 105119 105123 105121 105122

Distribution pattern

Nationwide

device · product 10 of 12

Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354

Z-1903-2019
Recall number
Z-1903-2019
Initiated
June 06, 2019
Classification
Class II
Status
Terminated
Quantity
15

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Code information

Serial Numbers: 111005 111000 111002 111125 111123 111109 111128 111124 111122 111104 111106 111121 111127 111137 111135

Distribution pattern

Nationwide

device · product 11 of 12

Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355

Z-1904-2019
Recall number
Z-1904-2019
Initiated
June 06, 2019
Classification
Class II
Status
Terminated
Quantity
11

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Code information

Serial Numbers: 123049 123216 123046 123236 123211 123202 123043 123219 123240 123230 123246

Distribution pattern

Nationwide

device · product 12 of 12

Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000

Z-1905-2019
Recall number
Z-1905-2019
Initiated
June 06, 2019
Classification
Class II
Status
Terminated
Quantity
8

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Code information

Serial Numbers: 164021 164053 164055 164054 164088 164140 164113 164069

Distribution pattern

Nationwide