FDA recall Z-1409-2022

Aesculap Implant Systems LLC · Class II · device

Product

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

United States: NE

Key facts

Status
Completed
Initiation date
2021-02-19
Report date
2022-07-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1409-2022