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Confocal Microprobe Imaging System
Wuxi Hisky Medical Technologies Co.,Ltd. · Model BrightP660 · UDI-DI 06971679949867
OWN
Prescription
10
510(k) clearances
1,525
Adverse events (1 deaths)
4
Recalls
69
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-24 | Olympus Corporation of the Americas | Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the devic |
| 2022-10-17 | Visionsense, Ltd. | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. |
| 2022-10-17 | Visionsense, Ltd. | XXX |
| 2022-10-17 | Visionsense, Ltd. | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. |
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