Z-2139-2024 Class II Ongoing
FDA device recall Z-2139-2024 was initiated by Aesculap Inc on May 13, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 19 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2024
- Initiation Date
- May 13, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
Product Description
Aeos Robotic Digital Microscope, Product Code: PV010
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of AR, FL, IL, IN, KY, MI, NC, NE, OK, SD, TX.
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