Device product
Aeos Robotic Digital Microscope, Product Code: PV010
Z-2139-2024
Product summary
- Firm
- Aesculap Inc
- Event
- Event 94623
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19 units
- Official record key
device-enforcement:Z-2139-2024
Official wording
Reason: Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.
Code information: Product Code: PV010, UDI/DI: 04046955206742; Serial Numbers: 1011, 1005, 1057, 1032, 1038, 1054, 1036, 1060, 1056, 1089, 1093, 1027, 1061, 1004, 1026, 1035, 1097, 1084, 1063
Distribution pattern: US Nationwide distribution in the states of AR, FL, IL, IN, KY, MI, NC, NE, OK, SD, TX.
Derived failure modes
-
Unknown
Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.