Aesculap Implant Systems LLC Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AR, IN, NE, NC