Recall Z-0183-2024— Carl Zeiss Suzhou Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Carl Zeiss Suzhou Co., Ltd., initiated 2023-08-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Carl Zeiss Suzhou Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-18
- Firm location
- Suzhou, N/A, China
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.