Reported Oct 5, 2016 · Terminated

ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator…

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?

  • ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Lot codes and dates
  • 103 of 103 codes

    • Model # 08162815
    • 8168754 Serial # 10019
    • 10626
    • 10651
    • 10672.10678
    • 10702
    • 10703
    • 10706
    • 10712
    • 10758
    • 10767
    • 10804
    • 10625
    • 10063
    • 10770
    • 10831
    • 10008
    • 10786
    • 10789
    • 10756
    • 10045
    • 10589
    • 10698
    • 10642
    • 10792
    • 10822
    • 10821
    • 10849
    • 10850
    • 10592
    • 10676
    • 10785
    • 10047
    • 10722
    • 10665
    • 10754
    • 10004
    • 10007
    • 10823
    • 10002
    • 10803
    • 10074
    • 10778
    • 10046
    • 10762
    • 10835
    • 10694
    • 10844
    • 10603
    • 10788
    • 10600
    • 10634
    • 10570
    • 10815
    • 10744
    • 10624
    • 10513
    • 10015
    • 10805
    • 10635
Amount recalled
103 accelerators

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

Software patch installation to address several safety issues.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated May 10, 2018 · Data as of Sep 19, 6:00 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.