FDAFDA · Alimentos y medicamentos·N.º oficial Z-0531-2013
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
Publicado el 26 de diciembre de 2012 · Inicio del retiro: 5 de noviembre de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Varian Medical Systems, Inc. Oncology Systems
- Distribuidor
- Worldwide Distribution
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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