Reported Aug 26, 2015 · Terminated

Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and…

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 · 51 Valley Stream Pkwy · Malvern, PA · 19355-1406

Is this the product you have?

  • Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Lot codes and dates
  • Model Numbers of device
    • 10094135
    • 10094137
    • 10094139
    • 10094141
    • 10094142
    • 10094143
    • 10280959
  • with serial numbers

    586 of 586 codes

    • 146669
    • 153131
    • 153229
    • 146877
    • 157435
    • 146663
    • 147100
    • 147049
    • 147233
    • 136077
    • 147189
    • 147190
    • 153695
    • 157660
    • 153727
    • 157458
    • 146335
    • 146659
    • 153779
    • 146993
    • 153280
    • 153648
    • 153674
    • 160395
    • 160484
    • 135757
    • 136513
    • 136562
    • 147273
    • 157698
    • 147030
    • 147239
    • 146988
    • 160348
    • 157532
    • 160502
    • 146899
    • 135102
    • 153169
    • 146643
    • 136042
    • 153803
    • 146361
    • 146365
    • 146366
    • 146369
    • 146116
    • 146164
    • 146168
    • 153110
    • 160392
    • 147371
    • 160115
    • 135986
    • 157690
    • 154074
    • 154012
    • 147129
    • 135841
    • 153732
Amount recalled
586

Where it was sold

  • Nationwide

Why it was recalled

in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in "Bypass Fluoro" or to restart the system.

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

Want the full recall guide?

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 5, 2016 · Data as of Sep 19, 5:33 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.