International safety notice
Alert 2934 (Technosurveillance) - Elekta - Elekta Planning System - Monaco - Possibility that monitoring units are incorrectly sized when a specific workflow is followed.
Brazil / Anvisa · BRA · Aug 1, 2019
Key facts
| Title | Alert 2934 (Technosurveillance) - Elekta - Elekta Planning System - Monaco - Possibility that monitoring units are incorrectly sized when a specific workflow is followed. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Elekta Planning System Technical Name: Planning Software. ANVISA registration number: 80569320003 Risk Class: III Affected model: Monaco Affected serial numbers: devices with versions 5.10 and 5.11. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ELEKTA MEDICAL SYSTEMS COMÉRCIO E SERVIÇOS RADIOTERAPIA LTDA CNPJ 09528196000166 RUA CARNEIRO DA CUNHA 303 1º ANDAR VILCA DA SAÚDE CEP 04144000 SÃO PAULO SP TEL 11 5054 4550 EMAIL FABIOMOURAELEKTACOM FABRICANTE DO PRODUTO ELEKTA INC 13723 RIVERPORT DRIVE SUITE 100 MARYLAND HEIGHTS MISSOURI 63043 |
| Models | 80569320003 |
| Date | Aug 1, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 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