Reported Sep 30, 2015 · Terminated

ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist;…

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, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic
  • treatment of cancer Product UsageThe intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording
Lot codes and dates
  • ARTISTE - 08139789 ONCOR Avantgarde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression  07360717 PRIMUS - K993425 PRIMUS Plus  04504200 Syngo
  • RT Therapist - 08162815 serial numbers
    • 5177
    • 3761
    • 3981
    • 3998
    • 5096
    • 70-4161
    • 3354
    • 10570
    • 10793
    • 10794
    • 10796
    • 10795
    • 10798
    • 10814
    • 10792
    • 5300
    • 10046
    • 10549
    • 10687
    • 3624
    • 5350
    • 5784
    • 10586
    • 5830
    • 10010
    • 5419
Amount recalled
26

Where it was sold

  • Nationwide

Why it was recalled

A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.

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 Sep 1, 2016 · Data as of Sep 19, 6:15 PM UTC

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