Z-1348-2018 Class II Terminated
FDA device recall Z-1348-2018 was initiated by Nidek Inc. on December 20, 2017 and is designated Class II. Reason for recall: There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s. The recall status is terminated (terminated March 18, 2019). Affected quantity: 63 untis.
Recall Details
- Product Type
- Devices
- Report Date
- April 18, 2018
- Initiation Date
- December 20, 2017
- Termination Date
- March 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63 untis
Product Description
AUTO REF/KERATOMETER ARK-1s
Reason for Recall
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
Distribution Pattern
Distributed domestically to AK, AL, AR, CA, CO, DE, FL, GA, ID, IL, IN, MD, MI, MO, MT, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WV.
Code Information
Model No. ARK-1s, Serial No. 620337, 620340, 620341, 620343, 620345, 620349, 620350, 620355, 620356, 620359, 620363, 620370, 620371, 620374, 620376, 620377, 620380, 620381, 620384, 620387, 620389, 620391, 620394, 620398, 620400, 620403, 620404, 620407, 620410, 620412, 620415, 620417, 620418, 620420, 620422, 620425, 620427, 620429, 620433, 620435, 620437, 620440, 620444, 620445, 620447, 620450, 620452, 620454, 620455, 620459, 620462, 620464, 620466, 620469, 620471, 620474, 620477, 620478, 620480, 620482, 620485, 620487, 620489.