International safety notice
At the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization process of the laser fiber that is a component of the medical device. It was discovered that records could not confirm that the sterilization process was carried out according to specifications. The manufacturer of the laser body and fiber (Quanta System SpA) may not have We have decided to voluntarily recall the problematic laser fibers. To do.
Japan / PMDA Recalls · JPN · Apr 27, 2021
Key facts
| Title | At the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization process of the laser fiber that is a component of the medical device. It was discovered that records could not confirm that the sterilization process was carried out according to specifications. The manufacturer of the laser body and fiber (Quanta System SpA) may not have We have decided to voluntarily recall the problematic laser fibers. To do. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1)(2)(4) Pulsed holmium YAG laser (3) Thulium YAG laser Sales name: (1)Quanta Litho laser (2)Ｑｕａｎｔａ Ｃｙｂｅｒ Ｈｏ レーザ (3)Quanta Cyber TM 200W laser (4)Quanta Cyber Ho 100W laser |
| Manufacturer | Edap Technomed Co., Ltd. |
| Models | 550μm, 1000μm, OAF005513, OAF005511, 200μm, OAF702711, OAF009913, OAF703611, OAF402013, 365μm, OAF703613, OAF402011 and 3 more |
| Date | Apr 27, 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