FDA-Device2014-06-04Class II

Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer

Siemens Medical Solutions USA, Inc
Hazard

Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerator in combination with stereotactic accessories which have not been validated as being compatible with Siemens LINAC models.

Sold states
US Nationwide Distribution in the states of AL, ME, PA, IL, and CA.
Affected count
9
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1652-2014

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