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Recall Observatory FDA recall evidence

Device product

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

Z-1652-2014

April 01, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 67956
Status
Terminated
Classification
Class II
Quantity
9
Official record key
device-enforcement:Z-1652-2014

Official wording

Reason: 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.

Code information: material numbers and serial numbers: 1940035 2962 8139789 5833 8139789 5899 9401654 2113 1940035 2628 4504200 3066 4504200 3361 1940035 3873 1940035 2855

Distribution pattern: US Nationwide Distribution in the states of AL, ME, PA, IL, and CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.