International safety notice
Alert 2762 (Technosurveillance) - Elekta - Mosaiq - Possibility that fields planned with wedges are applied without wedges, with the consequent receipt of a higher dose than planned.
Brazil / Anvisa · BRA · Jan 11, 2019
Key facts
| Title | Alert 2762 (Technosurveillance) - Elekta - Mosaiq - Possibility that fields planned with wedges are applied without wedges, with the consequent receipt of a higher dose than planned. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: MOSAIQ Technical Name: Planning Software. ANVISA registration number: 80569320004 Risk Class: III Affected model: MOSAIQ and Sequencer Affected serial numbers: See attachment "List of units at risk" |
| 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 14042024333 100 MATILDA PLACE 5TH FLOOR SUNNYVALE CA 94086 |
| Models | 80569320004 |
| Date | Jan 11, 2019 |
| 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