International safety notice
Urgent Field Safety Notice for Optima Coil System, Prestige Coil System by BALT USA LLC
Germany / BfArM · DEU · Jan 15, 2024
Key facts
| Title | Urgent Field Safety Notice for Optima Coil System, Prestige Coil System by BALT USA LLC |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | Optima Coil System, Prestige Coil System |
| Manufacturer | BALT USA LLC |
| Models | OPTI0404CSFMX, OPTI0412HSFMXV04, F201100435, OPTI0306CSF10V02, F201100043, F200800234, F201100426, F201200794, F201100186, F210500127, F200900372, F201100184 and 1130 more |
| Date | Jan 15, 2024 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
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