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Medical Device Recalls
Class 2 Recall
ONCOR Avant Garde
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Date Recall
Initiated |
March 22, 2007
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| Date Posted |
November 09, 2007
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| Recall Number |
Z-0164-2008
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| 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
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| Code Information |
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.
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Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord
, California
94520-1200
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Reason For
Recall |
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."
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| Action |
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.".
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| Quantity in Commerce |
52 units
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| Distribution |
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
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