CLASS II ONGOING Device recall · Reported 6 Jul 2022 · FDA Enforcement Report

Artis Pheno, Interventional Fluoroscopic X-Ray System recalled

Siemens Medical Solutions USA is recalling Artis Pheno, Interventional Fluoroscopic X-Ray System, distributed nationwide in the US. The recall was initiated on 10 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 04056869046877 Serial numbers: 164140 164138 164159 164331 164332 164033 164287 164282 164210 164183 164184 164311 164142 164312 164071 164328 164034 164318 164244 164306 164155 164340 164189 164271 164277 164173 164292 164231 164095 164057 164054 164055 164132 164329 164072 164190 164048 164333 164025 164026 164027 164338 164094 164241 164326 164267 164186 164068 164121 164157 164019 164152 164161 164013 164069 164213 164073 164257 164293 164263 164298 164060 164083 164113 164021 164066 164362 164124 164125 164366 164279 164075 164074 164084 164086 164098 164028 164153 164330 164172 164295 164353 164234 164321 164242 164270 164275 164315 164344 164163 164158 164053 164171 164297 164134 164253 164188 164063 164064 164299 164300 164105 164160 164024 164080 164049 164240 164359 164227 164228 164018 164022 164250 164061 164187 164115 164011 164204 164205 164211 164212 164216 164100 164097 164269 164303 164322 164196 164355 164352 164168 164319 164201 164202 ***Updated 9/13/23*** 164088 164193

Quantity recalled136 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1294-2022
FDA event ID: 90507
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Jun 2022
FDA classified: 27 Jun 2022
Reported: 6 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

10 Jun 2022	Recall initiated by company
27 Jun 2022	Classified by FDA	+17 days
6 Jul 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000

Where it was distributed

Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Brazil Canada China Colombia Denmark Finland France Germany Hungary Indonesia Iran Italy Japan Kuwait Mexico Monaco Netherlands Norway Poland Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom United States Vietnam

Nationwide

Questions about this recall

Is Artis Pheno, Interventional Fluoroscopic X-Ray System recalled?

Yes. Siemens Medical Solutions USA recalled Artis Pheno, Interventional Fluoroscopic X-Ray System on 10 Jun 2022. The recall is Class II and its status is Ongoing. Recall number Z-1294-2022.

Why was it recalled?

Which lots are affected?

UDI-DI: 04056869046877 Serial numbers: 164140 164138 164159 164331 164332 164033 164287 164282 164210 164183 164184 164311 164142 164312 164071 164328 164034 164318 164244 164306 164155 164340 164189 164271 164277 164173 164292 164231 164095 164057 164054 164055 164132 164329 164072 164190 164048 164333 164025 164026 164027 164338 164094 164241 164326 164267 164186 164068 164121 164157 164019 164152 164161 164013 164069 164213 164073 164257 164293 164263 164298 164060 164083 164113 164021 164066 164362 164124 164125 164366 164279 164075 164074 164084 164086 164098 164028 164153 164330 164172 164295 164353 164234 164321 164242 164270 164275 164315 164344 164163 164158 164053 164171 164297 164134 164253 164188 164063 164064 164299 164300 164105 164160 164024 164080 164049 164240 164359 164227 164228 164018 164022 164250 164061 164187 164115 164011 164204 164205 164211 164212 164216 164100 164097 164269 164303 164322 164196 164355 164352 164168 164319 164201 164202 ***Updated 9/13/23*** 164088 164193

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

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