International safety notice
Some of the parts that make up the FDG synthesis cassette were found to have been made by a manufacturer that differs from the approved specifications. Based on this information, we have decided to carry out a voluntary recall of the products with the relevant lot numbers.
Japan / PMDA Recalls · JPN · Apr 12, 2024
Key facts
| Title | Some of the parts that make up the FDG synthesis cassette were found to have been made by a manufacturer that differs from the approved specifications. Based on this information, we have decided to carry out a voluntary recall of the products with the relevant lot numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Radiopharmaceutical synthesis equipment Commercial name: Radioactive medicinal drug synthesis equipment NEPTIS mosaic RS-02 |
| Manufacturer | JFE Engineering Co., Ltd. |
| Models | TM-H-220715003-1, TM-H-230118001-1, TM-H-220203001-1, TM-H-221017005-1, TM-H-210412001-1, TM-H-201201003-1, TM-H-210920004-1, TM-H-211209005-1, TM-H-210610003-1, TM-H-210422002-1, TM-H-220907004-1, TM-H-220613002-1 |
| Date | Apr 12, 2024 |
| 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