Class 2 Device Recall Varian brand ARIA Radiation Oncology

• Date Initiated by Firm: November 05, 2012
• Date Posted: December 17, 2012
• Recall Status: Terminated on March 03, 2014
• Recall Number: Z-0531-2013
• Recall Event ID: 63713
• 510(K)Number: K093527
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
• Code Information: CODES: HITOO28, HIT0963, HITl780, HIT242S, HIT4118RI, HIT0632M, HITIS87R4, HIT2208RS, HID088R6, HITOO32, HIT0983M, HITl800, HIT2434, HIT4263, HlT0632Rl, HlTlS89M, HIT2212, HIT3097, HITOO49M, HIT0983RI, HITI8S4, HIT244I, HIT438I, HIT0632R2, HITlS89Rl, HlT2237M, HIT316S, HITOl16M, HIT0983R2, HITl874, HIT2477M, HIT4439RI, HIT0668, HITIS89R2, HlT2237RI, HIT3206, HITOI16RI, HIT0998, HITl898, HIT2477RI, HIT4SSS, HIT0691M, HITIS89R3, HIT2267M, HIT3267, HIT0134, HITI036, HITl9S8, HlT2477R2, HIT4S92, HIT0691RI, HlTlS89R4, HlT2267RI, HIT3268, HITOISS, HITl119M, HITl968, HIT2477R3, HIT4627, HIT0691R2, HITlS89RS, HIT227SM, HIT3308, HITOI70M, HITII19RI, HIT2037M, HIT2SI2M, HIT477I, HIT0691R3, HITlS89R6, HIT227SRI, HIT3438M, HITOI70RI, HITI139, HIT2037RI, HIT2SI2RI, HlT4800, HIT0764, HITlS89R7, HIT227SR2, HIT3S13, HITOI70R2, HITll49M, HIT2037RII, HIT2S22, HIT4884, HIT0816, HITIS89R8, HlT227SR3, HIT3679, HITOI70R3, HITll49Rl, HIT2037R12, HlT2S46, HIT4888M, HIT0828, HITIS89R9, HIT227SR4, HIT3764RI, HlTOl82, HITI184Al, HIT2037RI3, HIT2S63M, HIT4888RI, HIT08S2, HITI622, HlT2291M, HlT377S, HITOl83, HlTll84M, HIT2037R14, HIT2S63RI, HIT4888R2, HIT090lM, HITI660M, HIT229IRI, HlT3796, HITOl91M, HITll84RI, HIT2037RIS, HIT2S63R2, HIT4888R3, HIT090lRI, HlTl660R2, HIT2291R2, HID910, HITOl91RI, HITI229, HIT2037R16, HIT2S63R3, HIT4894, HIT0926, HITl660R3, HlT2291R3, HIT3927M, HITOI91R2, HITI277, HIT2037R17, HIT2S63R4, HIT4896, HIT0933M, HlTI671, HIT2291R4, HlT3927RI, HIT0227, HITl363M, HlT2037R2, HIT2S91, HIT4903, HIT0933RI, HITl693, HIT229IRS, HlT3927R2, HIT0337M, HITl363RI, HlT2037R3, HIT26IS, HlT4906, HIT0933R2, HITl726, HIT2291R6, HIT394S, HIT0337RI, HITl4I2, HlT2037R4, HIT2643, HIT4909, HIT0933R3, HITl7S7, HlT2293, HlT3967, HIT0337R2, HITl430M, HIT2037RS, HlT264S, HlT4932M, HIT0933R4, HITl764M, HIT2336M, HIT4014, HIT0337R3, HITl430RI, HIT2037R6, HIT2834, HIT4932RI, HIT0933RS, HITI764RI, HIT2336RI, HIT4107, HIT0339M, HITI430R2, HIT2037R7, HIT286S, HIT4938, HIT0933R6, HITl767M, HIT2346M, HIT41l6, HIT0339RI, HITl430R3, HIT2037R8, HIT2894M, HIT4942M, HIT0933R7, HITI767RI, HIT2346RI, HIT41I8M, HIT0341M, HITI470M, HIT2037R9, HIT2894Rl, HIT4942RI, HIT0341RI, HITl470RI, HIT2067, HIT2894R2, HIT4947, HIT0342, HITl470R2, HIT209S, HIT2894R3, HIT4974, HIT0383, HITI498, HIT2102, HlT2943, HIT4975, HIT0397, HITlSI4, HIT2140, HlT29S3, HIT4982, HIT0432M, HITlS23M, HIT2I80, HIT2997, HITSOII, HIT0432RI, HITlS23RI, HIT2188, HIT3088M, HITS048, HIT0432R2, HITIS7S, HIT2208M, HIT3088RI, HITS061, HIT0468M, HITlS87M, HIT2208Rl, HIT3088R2, HITS088, HIT0468RI, HlTlS87RI, HIT2208R2, HIT3088R3, HITS089, HITOS3S, HlTlS87R2, HIT2208R3, HIT3088R4, HITSI16, HITOSSI, HITIS87R3, HIT2208R4, HIT3088R5, HITSl41
• FEI Number: 2916710
• Recalling Firm/ Manufacturer: Varian Medical Systems, Inc. Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: Mika Miettinen; 650-424-5731
• Manufacturer Reason for Recall: Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import.
• FDA Determined Cause: Software design
• Action: Varian sent an Urgent Medical Device Correction Urgent Field Safety Notice dated November 6, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that the plan was not converted unintentionally during import/export. Customers would be contacted by a Customer Service Representative when the correction was available to schedule installation on their system. Customers with questions were instructed to contact their local Varian Medical Systems Customer Support District or Regional Manager. US and Canada 1-888-827-4265. For questions regarding this recall call 650-424-5731.
• Quantity in Commerce: 264 units
• Distribution: Worldwide Distribution
• 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