—#118861

Product

Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031764, K060226, K982502, K993425
Affected lot / code info: All customers who use the BEAMVIEW for position verification imaging on Siemens MEVATRON series, PRIMART (limited release) PRIMUS and/or ONCOR or ARTIST Linac Systems.

Why it was recalled

The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue may have resulted in mistreatment of patients.

Root cause (FDA determination)

Process change control

Action the firm took

Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION" letter and Update instruction TH022/13/S beginning on May 29, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. July 19, 2013 - TH023/13/S was distributed is now in progress. This is the FILM Mode Physics Primer Addendum.

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 and countries of: Algeria, Angola, Argentina, Austria, Australia, Bahamas, Belgium, Bosnia Herzeg, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hungary, India, Indonesia, Italy, Iran, Iraq, Ireland, Japan, Jordan, Kenya, DPR of Korea, Kosovo, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Pakistan, Palestinian Ter, Peru, Philippines, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sri Lanka, South Africa, Sweden, Switzerlan, Taiwan, Thailand, Trinidad Tobago,Turkey, United Kingdom, Venezula, Vietnam, Rep of Yemen, and Zambia.

Timeline

Recall initiated: 2013-05-29
Posted by FDA: 2013-07-03
Terminated: 2014-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118861. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.