Class 2 Device Recall Aesculap Aeos Robotic Digital Microscope

• Date Initiated by Firm: May 13, 2024
• Date Posted: June 12, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2139-2024
• Recall Event ID: 94623
• Product Classification: Microscope, surgical, general & plastic surgery - Product Code FSO
• Product: Aeos Robotic Digital Microscope, Product Code: PV010
• Code Information: Product Code: PV010, UDI/DI: 04046955206742; Serial Numbers: 1011, 1005, 1057, 1032, 1038, 1054, 1036, 1060, 1056, 1089, 1093, 1027, 1061, 1004, 1026, 1035, 1097, 1084, 1063
• FEI Number: 2916714
• Recalling Firm/ Manufacturer: Aesculap Inc; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: Cynthia Bauer; 833-425-1464
• Manufacturer Reason for Recall: Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.
• FDA Determined Cause: Process control
• Action: On May 13, 2024, URGENT MEDICAL DEVICE FIELD CORRECTION letters were mailed to customers. Actions to be taken by the customer: 1. Review the Device Correction Notification in its entirety and ensure that all users in your organization of the device and other concerned persons are informed about this voluntary product correction. If you are a distributor, please forward this correction notification to your customers. The correction is to be extended to the end user/customer level. 2. Determine your current inventory of the affected material within your facility, cease use and quarantine product subject to correction. Do not destroy any affected product. (Once your completed Urgent Medical Device Form is received, a representative will be in contact to arrange for inspection and testing). 3. Utilizing the attached "Urgent Medical Device Correction Acknowledgement Form," record the total number of individual units in your posession. If you have no inventory, please enter zero (0) on the form. 4. Return the completed "Urgent Medical Device Correction Acknowledgement Form" to the Aesculap Inc. Quality Assurance Department by faxing the form to (610)849-1197 or e-mail to recalls@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your acknowledgement Form, an Aesculap representative will contact you to arrange inspection and testing of your devices by our authorized specialists. Should you identify a problem or safety concern with the product, please report promptly by contacting our Post-market Surveillance Department at 1-833-425-1464. Additionally, adverse reactions of quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program wither online, by regular mail or fax.
• Quantity in Commerce: 19 units
• Distribution: US Nationwide distribution in the states of AR, FL, IL, IN, KY, MI, NC, NE, OK, SD, TX.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.