Z-1710-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2015
- Initiation Date
- March 24, 2015
- Termination Date
- April 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114 units
Product Description
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
Reason for Recall
Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
Distribution Pattern
Us distribution only.
Code Information
Alll devices currently in use by consignees.