Reported Jul 6, 2022 · Ongoing

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

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 · 19355-1418

Is this the product you have?

  • Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Lot codes and dates
  • UDI-DI04056869046877
  • Serial numbers

    134 of 134 codes

    • 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
    ***Updated 9/13/23*** 164088 164193
Amount recalled
136 systems

Where it was sold

  • Nationwide

Why it was recalled

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.

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, 7:44 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.