Class 2 Device Recall ONCOR IMPRESSION

• Date Initiated by Firm: March 22, 2007
• Date Posted: November 09, 2007
• Recall Status: Terminated on December 18, 2010
• Recall Number: Z-0167-2008
• Recall Event ID: 38516
• 510(K)Number: K993425
• Product Classification: Medical Digital Linear Accelerator - Product Code IYE
• Product: ONCOR IMPRESSION,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857920, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520
• Code Information: MODEL NUMBER: 5857920 : Serial Numbers: 3878, 4021, 4078, 70-4143, 70-4207, 70-4235, 70-4257, 70-4344, 70-4296, 3974, 70-4165, 70-4167, 3729, 5022, 5035, 5074, 3811, 3845, 3962, 3973, 70-4152, 5015, 70-4238, 70-4374, 70-4386, 5024, 704083, 3894, 4048, 70-4276, 70-4277, 70-4281, 3883, 70-4083.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 4040 Nelson Ave; Concord CA 94520-1200
• For Additional Information Contact: 925-246-8200
• Manufacturer 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."
• FDA Determined Cause: Software design
• 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."
• Quantity in Commerce: 34 units
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE