Class 2 Device Recall AEOS Digital Microscope System

• Date Initiated by Firm: February 19, 2021
• Create Date: July 19, 2022
• Recall Status: Completed
• Recall Number: Z-1409-2022
• Recall Event ID: 90532
• Product Classification: Microscope, surgical, general & plastic surgery - Product Code FSO
• Product: Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
• Code Information: UDI-DI: 04046955206742, Serial Number: SN1004
• Recalling Firm/ Manufacturer: Aesculap Implant Systems LLC; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: Lindsay Chormiak; 800-258-1946
• Manufacturer Reason for Recall: Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
• FDA Determined Cause: Material/Component Contamination
• 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.
• Quantity in Commerce: 1
• Distribution: United States: NE
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.