Device product
OPMI LUMERA 300, REF 6137
Z-0183-2024
Product summary
- Event
- Event 93146
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-0183-2024
Official wording
Reason: Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.
Code information: UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613
Distribution pattern: US Nationwide distribution in the states of MD, TX, CA, GA, LA.
Derived failure modes
-
Unknown
Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.