FDA Enforcement
Class II
Ongoing
OPMI LUMERA 300, REF 6137
Recall: Z-0183-2024
·
Reported November 1, 2023
Enforcement
- Recall Number
- Z-0183-2024
- Event ID
- 93146
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Carl Zeiss Suzhou Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 1, 2023
- Initiation Date
- August 18, 2023
- Classification Date
- October 26, 2023
- Address
- Modern Industrial Square 3b, No. 333 Xingpu Road; Kunshan, Suzhou, N/A, N/A, China
Description
OPMI LUMERA 300, REF 6137
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 Info
UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613
Distribution
US Nationwide distribution in the states of MD, TX, CA, GA, LA.
Quantity
8