Reported Jul 14, 2021 · Ongoing

ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures.…

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355

Is this the product you have?

  • ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures
  • Model10849000
Lot codes and dates
  • Software VE10B
  • Serial Numbers

    116 of 116 codes

    • 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
Amount recalled
116 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:58 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.