CLASS II ONGOING Device recall · Reported 14 Jul 2021 · FDA Enforcement Report

Artis pheno- angiography systems developed for single recalled

Siemens Medical Solutions USA is recalling Artis pheno- angiography systems developed for single and biplane diagnostic imaging and, distributed nationwide in the US. The recall was initiated on 27 May 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware VE10B. Serial Numbers: 164138 164159 164033 164287 164282 164210 164183 164184 164311 164142 164071 164328 164034 164318 164244 164242 164306 164155 164189 164271 164277 164173 164292 164231 164057 164054 164055 164080 164132 164329 164072 164088 164190 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 164124 164125 164279 164075 164074 164084 164086 164098 164028 164153 164330 164295 164234 164321 164270 164275 164315 164163 164158 164053 164171 164134 164253 164188 164063 164064 164299 164300 164105 164160 164024 164049 164240 164227 164228 164018 164022 164250 164061 164187 164115 164322 164269 164303 164204 164205 164211 164212 164216 164196 164168 164319 164201 164202

Quantity recalled116 units

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-2029-2021
FDA event ID: 88216
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 27 May 2021
FDA classified: 7 Jul 2021
Reported: 14 Jul 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

27 May 2021	Recall initiated by company
7 Jul 2021	Classified by FDA	+41 days
14 Jul 2021	Published in enforcement report	+7 days

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

Reason for recall

Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000

Where it was distributed

US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Software VE10B. Serial Numbers: 164138 164159 164033 164287 164282 164210 164183 164184 164311 164142 164071 164328 164034 164318 164244 164242 164306 164155 164189 164271 164277 164173 164292 164231 164057 164054 164055 164080 164132 164329 164072 164088 164190 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 164124 164125 164279 164075 164074 164084 164086 164098 164028 164153 164330 164295 164234 164321 164270 164275 164315 164163 164158 164053 164171 164134 164253 164188 164063 164064 164299 164300 164105 164160 164024 164049 164240 164227 164228 164018 164022 164250 164061 164187 164115 164322 164269 164303 164204 164205 164211 164212 164216 164196 164168 164319 164201 164202

Where was it sold?

US Nationwide

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 26 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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