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Recall Observatory FDA recall evidence

Device product

Aeos Robotic Digital Microscope, Product Code: PV010

Z-2139-2024

May 13, 2024

Class II

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

    reason.no_named_rule · v1.0.0

    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.