Reported Dec 10, 2014 · Terminated

The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different…

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

Is this the product you have?

  • The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
Lot codes and dates
  • model numbers
    • 10094135
    • 10094137
    • 10094139
    • 10094141
    • 10094142
    • 10094143
    • 10280959
  • with serial numbers

    1,130 of 1,130 codes

    • 153229
    • 153131
    • 146669
    • 146877
    • 146996
    • 157435
    • 146663
    • 147100
    • 147233
    • 147049
    • 136077
    • 135746
    • 153172
    • 135229
    • 160313
    • 146174
    • 153315
    • 153318
    • 153317
    • 146121
    • 146710
    • 146945
    • 153992
    • 147084
    • 147189
    • 147190
    • 153335
    • 153695
    • 135120
    • 135322
    • 146679
    • 153102
    • 153101
    • 146232
    • 157660
    • 153727
    • 146728
    • 146408
    • 146409
    • 157458
    • 153216
    • 146335
    • 153779
    • 146659
    • 146993
    • 153280
    • 153648
    • 153674
    • 160395
    • 153166
    • 146898
    • 146965
    • 160484
    • 135757
    • 136513
    • 153700
    • 154096
    • 135000
    • 136562
    • 146221
Amount recalled
1131

Where it was sold

  • Nationwide
  • PR

Why it was recalled

There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Block Radiation" key on the touch screen control. If this behavior occurs, the system image generation function is not available for patient examinations without switching the system off and back on again manually. This

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

Notice updated Mar 30, 2015 · Data as of Sep 19, 4:44 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.