International safety notice
Urgent Field Safety Notice for Soltive Laser System by Gyrus ACMI, Inc.
Germany / BfArM · DEU · Apr 23, 2025
Key facts
| Title | Urgent Field Safety Notice for Soltive Laser System by Gyrus ACMI, Inc. |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | Soltive Laser System |
| Manufacturer | Gyrus ACMI, Inc. |
| Models | 06-SOLTIVE, FY25-EMEA-12-FY25-008, FY24-EMEA-36-FY24-OSTA, 00821925044111, 00821925044135 |
| Date | Apr 23, 2025 |
| Regulator page | bfarm.de |
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