Recall Z-2139-2024 ยท FSO Microscope, Surgical, General & Plastic Surgery
Aesculap Inc
Aeos Robotic Digital Microscope, Product Code: PV010
| Date | Jun 12, 2024 (initiated May 13, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 |
| Quantity | 19 units |
| Distribution | US Nationwide distribution in the states of AR, FL, IL, IN, KY, MI, NC, NE, OK, SD, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.