Z-1409-2022 Class II
FDA device recall Z-1409-2022 was initiated by Aesculap Implant Systems LLC on February 19, 2021 and is designated Class II. Reason for recall: Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- February 19, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Reason for Recall
Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
Distribution Pattern
United States: NE
Code Information
UDI-DI: 04046955206742, Serial Number: SN1004