Medical device recalls Moderate risk

Aesculap Implant Systems LLC recalls Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010

Recall date
February 19, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1409-2022
FDA classification
Class II
Brand / firm
Aesculap Implant Systems LLC
Sold / distributed
United States: NE

Why it was recalled

Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010

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