Ziemer FEMTO LDV Z2, Z4, and Z6 Lasers Recalled for Monitor Overheating
Ziemer USA Inc. is recalling five FEMTO LDV femtosecond surgical lasers because a controller board defect may cause the video monitor to overheat and shut off.
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 2/5 (Moderate).
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 a potential equipment malfunction (monitor shutdown) without reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Ziemer USA Inc. is recalling five units of the FEMTO LDV Z2, Z4, and Z6 Femtosecond Surgical Lasers. These ophthalmic surgical lasers are indicated for use in creating corneal incisions for LASIK surgery and other treatments requiring lamellar resection of the cornea.
The recall is due to a defect in the controller board that can cause the condenser to the video monitor to become too warm. This overheating could potentially cause the video monitor to shut off during use.
The affected units were distributed worldwide, including nationwide in the United States (specifically New Jersey and Illinois) and internationally to Finland, Japan, and Germany. The specific serial numbers for the recalled units are FLM4135, FLM3281, FLM2963, FLM3907, and FLM3817. Healthcare providers should contact Ziemer USA Inc. for instructions on how to address the defect.
The recalled product
- Product
- 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal…
- Manufacturer
- Ziemer Usa Inc
- Affected units
- 5
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 (5)
- Serial Numbers: FLM4135
- FLM3281
- FLM2963
- FLM3907
- FLM3817
Distribution
Related recalls
Same manufacturer · Ziemer Usa Inc
See all →- ModerateZiemer Femto LDV Z-Generation Lasers Recalled for Missing Starter Kits
FDA (Devices) · 2015-01-21
Same hazard · equipment malfunction
See all →- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereHologic Selenia Dimensions Mammography Systems Loose Internal Bolts
FDA (Devices) · 2026-05-20
Similar recalls
- ModerateZiemer Femto LDV Z-Generation Lasers Recalled for Missing Starter Kits
FDA (Devices) · 2015-01-21
- ModerateSIE AG Recalls FEMTO LDV Z8 Femtosecond Surgical Lasers
FDA (Devices) · 2018-04-04
- SevereNidek Excimer Laser System Recalled Due to Fuse Holder Contact Failure
FDA (Devices) · 2014-11-26
- Severe
- HighZPLP Distal Lateral Fibular Plates Recalled for Defective Threading
FDA (Devices) · 2024-05-08
- ModerateNidek EC-5000 Excimer Laser System Recalled for Unapproved Manual Feature
FDA (Devices) · 2015-06-10