Recall Z-1409-2022
Aesculap Implant Systems LLC · initiated February 19, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Codes / lots: UDI-DI: 04046955206742, Serial Number: SN1004
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 taken
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.
Details
- Recall number
- Z-1409-2022
- Initiated
- February 19, 2021
- Product code
- FSO – Microscope, Surgical, General & Plastic Surgery
- Quantity
- 1
- Distribution
- United States: NE
- Recalling firm
- Aesculap Implant Systems LLC, Center Valley, PA