—#128108

Product

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

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031764, K072485, K790688, K982502
Affected lot / code info: material numbers: 01940035, 04504200, 05672977, 05693908, 05857912, 05857920, 08139789, 08319758, 08490005, 08515520, 09401654, 09401746, 09822693, with serial numbers below 3094.

Why it was recalled

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.

Root cause (FDA determination)

Use error

Action the firm took

An Urgent Medical Device Correction Field Safety Notice Letter was sent to end users on/about June 2014 which described the product, problem, and actions to be taken to avoid encountering the safety risk to patients and users.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

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

Timeline

Recall initiated: 2014-05-28
Posted by FDA: 2014-08-10
Terminated: 2015-07-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128108. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.