FDA Enforcement
Class II
Ongoing
Aeos Robotic Digital Microscope, Product Code: PV010
Recall: Z-2139-2024
·
Reported June 19, 2024
Enforcement
- Recall Number
- Z-2139-2024
- Event ID
- 94623
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Aesculap Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- June 19, 2024
- Initiation Date
- May 13, 2024
- Classification Date
- June 12, 2024
- Address
- 3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States
Description
Aeos Robotic Digital Microscope, Product Code: PV010
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 Info
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
US Nationwide distribution in the states of AR, FL, IL, IN, KY, MI, NC, NE, OK, SD, TX.
Quantity
19 units