Nidek Excimer Laser System Recalled Due to Fuse Holder Contact Failure
Nidek Inc is recalling 14 EC-5000 CXIII Excimer Laser Corneal Surgery Systems because a contact failure in fuse holders could cause serious adverse events for patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the defect 'could cause a serious adverse event for the patient,' which aligns with the rubric criterion for 'significant injury' reports or risk of serious harm, warranting a score of 4.
Plain-English summary
Nidek Inc is recalling 14 units of the EC-5000 CXIII Excimer Laser Corneal Surgery System. This ophthalmic device is used for corneal surgery and includes a laser generator, beam delivery unit, optical system, gas system, and computer control.
The recall was initiated because a contact failure was detected in the F1 and F4 fuse holders. This defect could cause a serious adverse event for the patient during use.
The affected units were distributed in the United States, including Colorado, New York, Missouri, Louisiana, Maine, California, Michigan, Arizona, Connecticut, and Florida. The specific serial numbers for the recalled units are 530054, 530055, 530070, 530073, 530078, 530082, 530086, 530087, 530098, 530106, 530121, 530123, 530150, and 530155. Users should contact Nidek Inc for instructions on how to address this issue.
The recalled product
- Product
- Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for…
- Manufacturer
- Nidek Inc
- Affected units
- 14
Distribution
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