International safety notice
Alert 2664 (Technovigilance) - Varian Medical Systems Brasil Ltda - TrueBeam - Possibility of unintentional replacement of the treatment plan with gating.
Brazil / Anvisa · BRA · Sep 4, 2018
Key facts
| Title | Alert 2664 (Technovigilance) - Varian Medical Systems Brasil Ltda - TrueBeam - Possibility of unintentional replacement of the treatment plan with gating. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: TrueBeam Technical Name: Linear Accelerator ANVISA registration number: 10405410022 Risk Class: III Affected model: TrueBeam and TrueBeam STX Affected serial numbers: H192357 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO VARIAN MEDICAL SYSTEMS BRASIL LTDA CNPJ 03009915000156 RUA SÃO CARLOS DO PINHAL 696 7 ANDAR SÃO PAULO SP TEL 1134572655 EMAIL FERNANDOMESQUITAVARIANCOM FABRICANTE DO PRODUTO VARIAN MEDICAL SYSTEMS INC 911 HANSEN WAY PALO ALTO CA ESTADOS UNIDOS |
| Models | 10405410022, H192357 |
| Date | Sep 4, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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