Z-1494-2017 Class II Terminated
FDA device recall Z-1494-2017 was initiated by Nidek Inc on February 1, 2017 and is designated Class II. Reason for recall: During treatment planning, the procedure was programmed with an unintended (wrong) correction. The recall status is terminated (terminated December 5, 2017). Affected quantity: 29.
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2017
- Initiation Date
- February 1, 2017
- Termination Date
- December 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29
Product Description
Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of 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 system control.
Reason for Recall
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
Distribution Pattern
Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.
Code Information
Software version 1.11 and 1.12. Serial numbers of Affected devices: MNE0009; NVE0002; OH00295; NC00185; CAE0016; COE0008; MI00131; GA00241; CAE0007; VAE0004; MI00131; CAE0031; AZ00167; COE0011; CA00561; PAE0003; TN00168; MNE0009; WA00246; CAE0047; OHE0005; WAE0008; MI00244; NY00473; CAE0007; WAE0008; NVE0002; WA00233; CAE0016.