Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Summary
The FDA issued a Class II for Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microsco by Aesculap Implant Systems LLC. Reason: Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system..
Details
Source
Device Recall
External ID
Z-1409-2022
Action Date
2022-07-27
Status
Completed
Category
device
Product Description
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Lot/Code Info: UDI-DI: 04046955206742, Serial Number: SN1004
Quantity Affected: 1
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-02-19
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aesculap Implant Systems LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aesculap Implant Systems LLC have FDA actions?
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1409-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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