International safety notice
The methacrylate used in the "Serbix applicator" (hereinafter referred to as "this component"), which is a component of this product. We have confirmed that the biological safety evaluation of resin (Note 2, hereinafter referred to as this raw material) is insufficient. This component has already been manufactured and it is difficult to carry out further biological safety evaluation, so this component has been manufactured independently. We have decided to carry out a main collection. (Note 2) Raw materials that may come into contact with mucous membranes.
Japan / PMDA Recalls · JPN · Sep 10, 2021
Key facts
| Title | The methacrylate used in the "Serbix applicator" (hereinafter referred to as "this component"), which is a component of this product. We have confirmed that the biological safety evaluation of resin (Note 2, hereinafter referred to as this raw material) is insufficient. This component has already been manufactured and it is difficult to carry out further biological safety evaluation, so this component has been manufactured independently. We have decided to carry out a main collection. (Note 2) Raw materials that may come into contact with mucous membranes. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Non-Central Circulatory System General Purpose Afterloading Brachytherapy Device Applicator Brand name: Varisource Applicator II |
| Manufacturer | Varian Medical Systems Co., Ltd. |
| Date | Sep 10, 2021 |
| Regulator page | info.pmda.go.jp |
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