Class 2 Device Recall Clinac

• Date Initiated by Firm: August 31, 2006
• Date Posted: November 16, 2006
• Recall Status: Terminated on December 04, 2007
• Recall Number: Z-0194-2007
• Recall Event ID: 36555
• 510(K)Number: K904264 K913119
• Product Classification: linear accelerator - Product Code IYE
• Product: Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX)
• Code Information: Serial numbers H272325, H291060, H271879, H273040, H272187, H272434
• Recalling Firm/ Manufacturer: Varian Medical Systems Inc; 911 Hansen Way; Palo Alto CA 94304
• For Additional Information Contact: Dale Reynolds; 650-424-6640
• Manufacturer Reason for Recall: The chain holding the device gantry in position may break.
• FDA Determined Cause: Process control
• Action: On 8/31/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
• Quantity in Commerce: 254 units
• Distribution: Worldwide, including USA, England, Taiwan, Switzerland, Sweden, South Korea, Portugal, Poland, Norway, New Zealand, Netherlands, Malaysia, Japan, Italy, Germany, France, Denmark, Czech Republic, Colombia, China, Canada, Belgium, Australia and Venezuela.
• 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; 510(K)s with Product Code = IYE