Ziemer Femto LDV Z-Generation Lasers Recalled for Missing Starter Kits
Ziemer USA Inc. is recalling 26 Femto LDV Z-Generation femtosecond surgical lasers because they were not shipped with the required Starter Kits.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves missing components (Starter Kits) rather than a direct safety defect or reported injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ziemer USA Inc. is recalling 26 units of the Femto LDV Z-Generation femtosecond surgical laser. These devices are used to perform ophthalmic surgeries. The recall was initiated because the devices were not shipped with the Starter Kits.
The affected units were distributed nationwide in the United States, specifically in Alabama, California, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Pennsylvania, Texas, Virginia, and Washington. The recall covers specific serial numbers listed in the agency's official documentation.
Healthcare facilities and consumers who possess these specific laser units should stop using them and contact Ziemer USA Inc. for further instructions regarding the missing components.
The recalled product
- Product
- Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
- Manufacturer
- Ziemer Usa Inc
- Hazard
- Affected units
- 26
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 (20)
- Serial Numbers: FLM4184
- FLM2003
- FLM3324
- FLM1409
- FLM2906
- FLM2136
- FLM4948
- FLM3134
- FLM4587
- FLM3281
- FLM2179
- FLM1467
- FLM1239
- FLM3361
- FLM3319
- FLM3685
- FLM2915
- FLM1230
- FLM3229
- FLM4094
Distribution
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