Reported Apr 17, 2013 · Terminated

ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family…

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 · 757 Arnold Dr Ste A · Martinez, CA · 94553-3615

Is this the product you have?

  • ELEKTA MOSAIQ SW version below 2.41
  • 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
Lot codes and dates
  • System No. 10568605:100044

    103 of 103 codes

    • 100078
    • 100085
    • 100088
    • 100098
    • 100135
    • 100020
    • 100025
    • 100001
    • 100002
    • 100003
    • 100004
    • 100006
    • 100007
    • 100008
    • 100009
    • 100010
    • 100011
    • 100012
    • 100013
    • 100014
    • 100016
    • 100017
    • 100019
    • 100023
    • 100024
    • 100028
    • 100029
    • 100030
    • 100031
    • 100032
    • 100033
    • 100034
    • 100035
    • 100036
    • 100037
    • 100038
    • 100039
    • 100040
    • 100041
    • 100042
    • 100045
    • 100047
    • 100049
    • 100051
    • 100052
    • 100053
    • 100054
    • 100056
    • 100058
    • 100059
    • 100060
    • 100061
    • 100062
    • 100063
    • 100065
    • 100066
    • 100068
    • 100069
    • 100070
    • 100071
Amount recalled
101

Why it was recalled

A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc.

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 Jul 19, 2013 · Data as of Sep 19, 5:31 PM UTC

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