—#65670

Product

ONCOR Avant Garde,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5863472,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031764
Affected lot / code info: MODEL NUMBER: 5863472: Serial Numbers: 3738, 3817, 3904, 3905, 3926, 3934, 3938, 3987, 3988, 4016, 4079, 4082, 4095, 70-4077, 70-4113, 70-4188, 70-4197, 70-4283, 70-4368, 3852, 70-4168, 70-4169, 3737, 3739, 3758, 3806, 3856, 3884, 3891, 3912, 3929, 3937, 3941, 3944, 70-4163, 70-4291, 70-4325, 3895, 3896, 4049, 70-4201, 70-4297, 70-4314, 70-4184, 70-4213, 70-4223, 5012, 70-4311, 3881, 70-4324, 70-4217, 3932.

Why it was recalled

Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."

Root cause (FDA determination)

Software design

Action the firm took

Distribution of Update Instructions TH007/07/S was sent to all affected sites on March 26, 2007. This was intended to inform users that Service Mode is only for use by authorized personnel, and that unauthorized and/or incorrect softpot parameter changes performed in Service Mode can result in the risk of patient mistreatment. Current control system software versions do not allow unplanned Dosimetry calibration data sets to be erroneously copied during "Service Mode."

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide:USA including states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virgina, Wisconsin, and Wyoming and FOREIGN COUNTRIES: Canada, Mexico, Serbia Montenegro, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzeg-Bosnia, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, DPR of Korea, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uzbekistan, Venezuela, Vietnam, and Zambia

Timeline

Recall initiated: 2007-03-22
Posted by FDA: 2007-11-09
Terminated: 2010-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65670. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.