International safety notice
From the manufacturer Electro Medical Systems S.A., at the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization process, Since the possibility of sterilization being performed under inappropriate sterilization process cannot be ruled out, we have informed you that we will conduct a voluntary recall. received. Therefore, we will carry out a voluntary recall of the affected products.
Japan / PMDA Recalls · JPN · Apr 21, 2021
Key facts
| Title | From the manufacturer Electro Medical Systems S.A., at the manufacturing facility (Steril Milano S.r.l.) that performs the sterilization process, Since the possibility of sterilization being performed under inappropriate sterilization process cannot be ruled out, we have informed you that we will conduct a voluntary recall. received. Therefore, we will carry out a voluntary recall of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Pulsholmium YAG laser Sales name: EMS Laser Crust |
| Manufacturer | Adachi Co., Ltd. |
| Models | FR-177, B170500, B382405, B180400, B180900, B164270, FR-273, FR-181, B174760, B390721, B181500, B174730 and 19 more |
| Date | Apr 21, 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