International safety notice
Alert 2777 (Technovigilance) - Varian Medical Systems Brasil Ltda - ARIA - Possibility of displaying information from patient records unintentionally.
Brazil / Anvisa · BRA · Jan 17, 2019
Key facts
| Title | Alert 2777 (Technovigilance) - Varian Medical Systems Brasil Ltda - ARIA - Possibility of displaying information from patient records unintentionally. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: ARIA Technical Name: Radiotherapy treatment planning software ANVISA registration number: 10405410013 Risk Class: III Affected model: N/A Affected serial numbers: HIT8633, HIT8809, HIT8739, HIT3479, HIT8740, HIT4558, HIT8593, HIT2388, HIT3432, HIT8054, HIT1975, HIT3468, HIT5549, HIT4359, HIT8607, HIT8648, HIT33 88. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO VARIAN MEDICAL SYSTEMS BRASIL LTDA CNPJ 03009915000156 RUA SÃO CARLOS DO PINHAL 696 SÃO PAULO SP TEL 1134572655 EMAIL FERNANDOMESQUITAVARIANCOM FABRICANTE DO PRODUTO VARIAN MEDICAL SYSTEMS INC 911 HANSEN WAY PALO ALTO CA ESTADOS UNIDOS |
| Models | HIT8739, HIT3432, HIT2388, HIT5549, HIT8740, HIT3468, HIT4359, HIT8648, HIT8054, HIT3479, HIT4558, HIT8607 and 6 more |
| Date | Jan 17, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1