FDA-Device2013-04-17Class II

ELEKTA MOSAIQ SW version below 2.41 Product Usage: The 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.

Siemens Medical Solutions USA, Inc
Hazard

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

Sold states
Worldwide Distribution
Affected count
101
Manufactured in
757 Arnold Dr Ste A, Martinez, CA, United States
Products
ELEKTA MOSAIQ SW version below 2.41 Product Usage: The 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1077-2013

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