FDA Device recall Z-0531-2013

Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Af…

FDA Device
Class II
terminated
Published 2012-12-26

On 2012-12-26 the FDA classified a Class II recall of Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Af… by Varian Medical Systems Oncology Systems, citing 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 fi….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0531-2013
Classification	Class II
Status	terminated
Initiated	2012-11-05
Published	2012-12-26
Last updated	2026-09-13 11:53 UTC
Company	Varian Medical Systems Oncology Systems
Distribution	n/a

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

Reason

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.

Identifiers

code_info	CODES: HITOO28, HIT0963, HITl780, HIT242S, HIT4118RI, HIT0632M, HITIS87R4, HIT2208RS, HID088R6, HITOO32, HIT0983M, HI… 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,

code_info

CODES: HITOO28, HIT0963, HITl780, HIT242S, HIT4118RI, HIT0632M, HITIS87R4, HIT2208RS, HID088R6, HITOO32, HIT0983M, HI…

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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0531-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.