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Completed

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

FDA Recall Z-1409-2022 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusCompleted
Product CodeFSO
Date Initiated2021-02-19
Product Quantity1

Reason for Recall

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

Firm Action

An Urgent Market Withdrawal Notification letter issued February 19, 2021 was mailed USPS certified. The letter identifies the Universal Robot UR5 arm as part of hte Aesculap Aeos System and requests the customer return the acknowledgement form and schedule repair by service technician.

Root Cause

Material/Component Contamination

Distribution Pattern

United States: NE

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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