International safety notice
Alert 2649 (Technosurveillance) - Elekta Medical Systems Ltda - Elekta Linear Accelerator Equipment may remain in an unexpected tilted state after completion of a specific workflow.
Brazil / Anvisa · BRA · Aug 22, 2018
Key facts
| Title | Alert 2649 (Technosurveillance) - Elekta Medical Systems Ltda - Elekta Linear Accelerator Equipment may remain in an unexpected tilted state after completion of a specific workflow. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Elekta Linear Accelerator Technical Name: Linear Accelerator ANVISA registration number: 80569320007 Risk Class: III Affected model: HexaPOD evo module Affected Serial Numbers:- |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ELEKTA MEDICAL SYSTEMS COMÉRCIO E SERVIÇOS PARA RADIOTERAPIA LTDA RUA CARNEIRO DA CUNHA 303 1º ANDAR VILA DA SAÚDE CEP 04144000 SÃO PAULO SP TEL 11 5054 4550 EMAIL FABIOMOURAELEKTACOM FABRICANTE DO PRODUTO MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH ALEMANHA |
| Models | 80569320007 |
| Date | Aug 22, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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