Class 2 Device Recall Aeos

• Date Initiated by Firm: July 14, 2022
• Create Date: August 11, 2022
• Recall Status: Terminated on February 07, 2025
• Recall Number: Z-1516-2022
• Recall Event ID: 90641
• Product Classification: Microscope, surgical, general & plastic surgery - Product Code FSO
• Product: Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
• Code Information: GUIDID: 04046955206742 Serial Numbers: 1004; 1026; 1032; 1035; 1036
• FEI Number: 2916714
• Recalling Firm/ Manufacturer: Aesculap Implant Systems LLC; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: SAME; 800-258-1946
• Manufacturer Reason for Recall: Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
• FDA Determined Cause: Software design
• Action: The firm, Aesculap Inc., issued "URGENT MEDICAL DEVICE CORRECTION" letter dated July 14, 2022. Letter states reason for recall, health risk and action to take: Address the application error concerns, the product instructions for use (IFU) have been updated and a new software version for the Aeos Robotic Digital Microscope (version 2.8.1.115) has been released. All customers are being provided the updated IFU and software. Refer to Actions Required by Aesculap Inc. Customer/User below. 1. Review the Device Correction Notification in its entirety and notify users and other relevant personnel within your organization. 2. Download the updated product IFU and ensure all users are aware of the updates. To obtain the updated IFU, please perform the following steps: a. Using your organizations approved web browser (e.g. Google Chrome, Microsoft Edge, etc.), enter the URL: https://www.aesculapusaifus.com. b. In the search field enter the Item Number: PV010 and press Search c. Click on the file AEOS Digital Microscope IFU (TA015615). Note: You will need a PDF viewer such as Adobe Acrobat to view the file. d. Print or distribute the IFU to relevant personnel. Maintain a copy in close proximity to the device for easy reference by the users. 3. Complete the Product Correction Acknowledgement form. If you have no inventory remaining, enter zero (0) on the form. 4. Return the completed Product Correction Acknowledgement form to our Quality Assurance department by e-mailing to qa-recalls@aesculapusa.com, even if the total inventory in your possession is zero (0). 5. Once we have received your acknowledgement form an Aesculap representative will contact you to arrange for qualified Aesculap personnel to update the software on your device. Report any concerns or issues to our Postmarket Surveillance team by contacting ProductQualityExcellence@bbraunusa.com or by calling 1-833-425-1464.
• Quantity in Commerce: 5 units
• Distribution: US Distribution to states of: AR, IN, NE and NC
• 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.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.