Surgical Microscope Suspension Arm May Fail Due to Missing Screw
Carl Zeiss OPMI LUMERA 300 surgical microscopes may have a missing screw on the suspension arm, potentially allowing suspended components to fall and injure nearby persons. Eight units distributed in Maryland, Texas, California, Georgia, and Louisiana are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving surgical equipment with potential for fall-related injury due to structural failure. Although the hazard is real and documented, no illnesses or injuries have been reported in the source text. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported, warranting a Score 3 (High).
Plain-English summary
The OPMI LUMERA 300 (REF 6137) is a surgical microscope manufactured by Carl Zeiss Suzhou Co., Ltd. and used in ophthalmology procedures. Eight units have been recalled due to a potential safety defect in the suspension arm assembly.
The microscope's suspension arm may be missing a screw, which could allow suspended components to fall. If components fall on a person in the vicinity of the equipment, it could result in injury.
Eight units with the following serial numbers have been distributed nationwide in Maryland, Texas, California, Georgia, and Louisiana: 6137104455, 6137104627, 6137104623, 6137104678, 6137104233, 6137104620, 6137104480, and 6137104613.
Healthcare facilities and surgeons using affected microscopes should verify the integrity of the suspension arm fasteners and contact Carl Zeiss Suzhou Co., Ltd. for inspection, repair, or replacement.
The recalled product
- Product
- OPMI LUMERA 300, REF 6137
- Manufacturer
- Carl Zeiss Suzhou Co., Ltd.
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- UDI-DI/Serial Numbers: 06909262061375/6137104455
- 6137104627
- 6137104623
- 6137104678
- 6137104233
- 6137104620
- 6137104480
- 6137104613
Distribution
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