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Terminated

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 Recall Z-1663-2013 · Posted 2013-07-03

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2013-05-29
Date Terminated2014-01-14
Product Quantity1956 customers

Reason for Recall

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.

Firm Action

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.

Root Cause

Process change control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060226ONCOR EXPRESSIONSiemens Medical Solutions USA, Inc. · 2006-03-15K031764ONCOR AVANT-GARDE WITH COHERENCE WORKSPACESSiemens Medical Solutions USA, Inc. · 2003-09-05K993425PRIMUSSiemens Medical Solutions USA, Inc. · 1999-11-26K982502GENESIS IMRT LINEAR ACCELERATORSiemens Medical Solutions USA, Inc. · 1998-07-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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