Recall Z-2094-2019 ยท BRX Stool, Anesthesia
Gk Photonics Inc
Spectrum Laser Projection Series
| Date | Jul 10, 2019 |
| Status | Open, Classified |
| Reason | The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA's Manual Reset Mechanism requirement for laser projectors and could unintentionally expose the user and/or observers to high power laser radiation. It needs to be replaced for safety reasons. |
| Root cause | Radiation Control for Health and Safety Act |
| Distribution | Unknown |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.