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Recall Observatory FDA recall evidence

Device product

Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.

Z-2174-2014

May 28, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 68507
Status
Terminated
Classification
Class II
Quantity
160
Official record key
device-enforcement:Z-2174-2014

Official wording

Reason: A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.

Code information: material numbers: 01940035, 04504200, 05672977, 05693908, 05857912, 05857920, 08139789, 08319758, 08490005, 08515520, 09401654, 09401746, 09822693, with serial numbers below 3094.

Distribution pattern: Nationwide and ROW, including Canada and Mexico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.