Z-1853-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2014
- Initiation Date
- June 9, 2014
- Termination Date
- October 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- ~4,285 units RT-5100; 167 units of RT-3100
Product Description
RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.
Reason for Recall
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
Distribution Pattern
US distribution only.
Code Information
RT-5100 and RT-3100, various serial numbers.