Class 2 Device Recall TrueBeam and TrueBeam STx,

• Date Initiated by Firm: October 31, 2011
• Date Posted: December 02, 2011
• Recall Status: Terminated on July 25, 2012
• Recall Number: Z-0364-2012
• Recall Event ID: 60411
• 510(K)Number: K111106
• Product Classification: Accelerator, linear, medical - Product Code -IYE
• Product: TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
• Code Information: Model numbers: H191113, H191034, H191105, H191154, H191046, H191053, H191044, H191015, H191035, H191108, 191152, H191140, H191069, H191017, H191027, H191109, 191130, H191002, H191071, H191024, H191078, H191111, 191072, H191102, H191074, H191087, H191151, H191125, 191018, H191058, H191038, H191115, H191085, H191032, 191077, H191023, H191103, H191095, H191163, H191146, 191124, H191138, H191093, H191097, H191040, H191030, 191029, H191060, H191066, H191122, H191054, H191126, 191114, H191082, H191067, H191081, H191005, H191013, 191116, H191051, H191094, H191052, H191031, H191021, 191048, H191139, H191099, H191020, H191039, H191128, 191156, H191057, H191061, H191112, H191049, H191083, 191008, H191123, H191065, H191119, H191089, H191120, 191092, H191134, H191129, H191056, H191090, H191033, 191047, H191037, H191076, H191007, H191028, H191080, 191106, H191118, H191073, H191117, H191155, H191086, 191141, H191025, H191036, H191042, H191079, H191135, 191010, H191100, H191107, H191127, H191063, H191070, 191153, H191026, H191096, H191014, H191064, H191059, 191009, H191142, H191068, H191001, H191132, H191011, 191003, H191136, H191022, H191121, H191016, H191012, 191045, H191101, H191088, H191041, H191043, H191150, 191019, H191055, H191133, H191131, H191091, H191098, 191006 and H191110
• Recalling Firm/ Manufacturer: Varian Medical Systems, Inc. Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: Peter J. Coronado; 650-424-5731
• Manufacturer Reason for Recall: An anomaly has been identified with the TrueBeam and TrueBeam STx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape.
• FDA Determined Cause: Device Design
• Action: On 11/04/2011, an Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps. Varian is developing a corrective action for this issue. A customer service representative will contact you when the correction is available to schedule installation on your system. Questions regarding the letter should be directed to the Varian Oncology Help Desk Contact Information at USA and Canada: 1-888-827- 4265 or Europe +41-41-749-8844.
• Distribution: Worldwide distribution including the US and Internationally.

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 and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.