FDA Enforcement
Class II
Terminated
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Recall: Z-1516-2022
·
Reported August 17, 2022
Enforcement
- Recall Number
- Z-1516-2022
- Event ID
- 90641
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Aesculap Implant Systems LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- August 17, 2022
- Initiation Date
- July 14, 2022
- Classification Date
- August 11, 2022
- Termination Date
- February 7, 2025
- Address
- 3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States
Description
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Reason
Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
Code Info
GUIDID: 04046955206742 Serial Numbers: 1004; 1026; 1032; 1035; 1036
Distribution
US Distribution to states of: AR, IN, NE and NC
Quantity
5 units