Z-0183-2024 Class II Ongoing
FDA device recall Z-0183-2024 was initiated by Carl Zeiss Suzhou Co., Ltd. on August 18, 2023 and is designated Class II. Reason for recall: 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 recall status is ongoing. Affected quantity: 8.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- August 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
OPMI LUMERA 300, REF 6137
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of MD, TX, CA, GA, LA.
Code Information
UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, 6137104613