International safety notice
Alert 2761 (Technosurveillance) - Elekta - Mosaiq - Possibility that the configuration field has an incorrect isocenter.
Brazil / Anvisa · BRA · Jan 11, 2019
Key facts
| Title | Alert 2761 (Technosurveillance) - Elekta - Mosaiq - Possibility that the configuration field has an incorrect isocenter. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Mosaiq Technical Name: Planning Software. ANVISA registration number: 80569320004 Risk Class: III Affected model: Verion 2.64 SP9 and higher Affected serial numbers: MOSAIQ Software/15038-RO00/2.64.235; |
| 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 1 408 830 8023 IMPAC MEDICAL SYSTEMS INC 100 MATHILDA PLACE FIFTH FLOOR SUNNYVALE CA 94086 |
| Models | 2.64.235, 15038-RO00, 18320-RO01, 30004117-RO01, 30000535-RO01, 15068-RO01, 80569320004, 20468-RO02, 30001754-RO01 |
| Date | Jan 11, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 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