—#123180

Product

SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060226
Affected lot / code info: Serial Numbers: 5281, 5385, 5445

Why it was recalled

A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens sent an Urgent Medical Device Correction letter dated October 23, 2013 including the release of update instruction TH024/13/S to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 757 Arnold Dr, Ste A, Martinez, California 94553-3615

Distribution

Distribution pattern: Worldwide Distribution: USA (nationwide) including states of: FL, NC, NY, PA, TN, UT, and WI; and countries of: Angola, Brazil, Canada, P.R. China, Germany, India, Japan, Republic Korea, Poland, and Thailand.

Timeline

Recall initiated: 2013-10-23
Posted by FDA: 2013-12-03
Terminated: 2014-01-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #123180. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.