International safety notice
Alert 2668 (Technovigilance) - Varian Medical Systems Brasil Ltda - Three-Dimensional Planning System for Eclipse Radiotherapy - The AAA algorithm may display high concentration points with errors.
Brazil / Anvisa · BRA · Sep 10, 2018
Key facts
| Title | Alert 2668 (Technovigilance) - Varian Medical Systems Brasil Ltda - Three-Dimensional Planning System for Eclipse Radiotherapy - The AAA algorithm may display high concentration points with errors. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Eclipse Three-Dimensional Radiotherapy Planning System Technical Name: Treatment Planning Software for Radiotherapy ANVISA registration number: 10405410007 Risk Class: III Affected model: Eclipse Affected serial numbers: H48S659, H48K829, H48K830, H48K831, H48T255, H48S310, H48S875, H486103, H486104, H486105, H48L133, H48L134, H48L135, H48L136, H48C 905, H48C906, H48J623, H48T131, H48T385, H48E273, H48S873. |
| 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 | H486104, H48L134, H48T385, H48C905, H48L136, H48L135, H48K830, H48L133, H48T131, H486103, H48S873, H48S875 and 10 more |
| Date | Sep 10, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 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