Varian Medical Systems, Inc. Oncology Systems: Medical Device Recall in 2012 - (Recall #: Z-0531-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 5, 2012

Date Posted: December 26, 2012

Recall Number: Z-0531-2013

Event ID: 63713

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.

Status: Terminated

Product Quantity: 264 units

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

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated