Recall Z-1516-2022 ยท FSO Microscope, Surgical, General & Plastic Surgery
Aesculap Implant Systems LLC
Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
| Date | Jul 14, 2022 |
| Status | Terminated |
| Reason | Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available: |
| Root 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 |
| Quantity | 5 units |
| Distribution | US Distribution to states of: AR, IN, NE and NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.