International safety notice
Alert 2774 (Technosurveillance) - Varian - Eclipse Three-Dimensional Radiotherapy Planning System - Incorrect calculation of water equivalence interval for non-square 3D CT images.
Brazil / Anvisa · BRA · Jan 16, 2019
Key facts
| Title | Alert 2774 (Technosurveillance) - Varian - Eclipse Three-Dimensional Radiotherapy Planning System - Incorrect calculation of water equivalence interval for non-square 3D CT images. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Eclipse Three-Dimensional Radiotherapy Planning System Technical Name: Radiotherapy Treatment Planning Software ANVISA registration number: 10405410007 Risk Class: III Affected model: Eclipse Affected serial numbers: H487882, H487883, H487884, H489199, H489251, H48M318, H48M469, H48M470, H48M471, H48M472, H48M473, H48M475, H48M477, H48M478, H48I 183, H48I191, H48I193, H48J117, H48J118, H48J130, H48J131, H48Q498, H48Q499 , H48P937, H48J918, H48J919, H48J920, H48J921, H48J922 |
| 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 | H48J921, H487882, H489199, H487883, H48I191, H48J118, H48M318, 10405410007, H48M470, H48J918, H48Q499, H48M477 and 18 more |
| Date | Jan 16, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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