International safety notice
Alert 2951 (Technovigilance) - Varian Medical Systems Brasil Ltda - Afterloader for HDR Brachytherapy Gammamed IX Possibility of undocking at the tip to change interstitial needles from specific batches.
Brazil / Anvisa · BRA · Aug 16, 2019
Key facts
| Title | Alert 2951 (Technovigilance) - Varian Medical Systems Brasil Ltda - Afterloader for HDR Brachytherapy Gammamed IX Possibility of undocking at the tip to change interstitial needles from specific batches. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Gammamed IX HDR Brachytherapy Afterloader Technical Name: Brachytherapy System ANVISA registration number: 10405410015 Risk Class: III Affected model: N/A Affected serial numbers: H64C113, H641078 and H640336 - The item subject to the Recall is the accessory GM11009510 - Stainless steel interstitial needles, 17 gauge. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO VARIAN MEDICAL SYSTEMS BRASIL LTDA CNPJ 03009915000156 RUA SÃO CARLOS DO PINHAL 696 9 ANDAR SÃO PAULO SP TEL 1134572655 EMAIL FERNANDOMESQUITAVARIANCOM FABRICANTE DO PRODUTO VARIAN MEDICAL SYSTEMS INC 911 HANSEN WAY PALO ALTO CA ESTADOS UNIDOS |
| Models | H640336, H641078, 10405410015, H64C113, GM11009510 |
| Date | Aug 16, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 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