Home › Device types › REK
Research Laser
FDA product code REK · Class N · Unknown
0
Registered devices
1
Adverse events
5
Recalls
0
510(k) clearances
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-08 | Ithera Medical Gmbh | The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value |
| 2020-01-31 | 89 NORTH | The defect relates to firmware version lower than V02.13.00. It is controlling safety interlocks of the LDI; specifically, the potential for the LDI to enter a |
| 2019-09-27 | Energetiq Technology Inc | On September 27, 2019 Energetiq Technology (the manufacturer) discovered a problem with their EQ-400-RH-QZ and EQ-400-LH-BK products during routine manufacturin |
| 2011-04-28 | Zeiss, Carl Inc | The manufacturer confirmed that the opto-semiconductor sensors can be triggered by exposure to incandescent lighting. The safety interlock is in place to preve |
| 2011-04-28 | Zeiss, Carl Inc | The manufacturer confirmed that the opto-semiconductor sensors can be triggered by exposure to incandescent lighting. The safety interlock is in place to preve |
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