AUTO REF/KERATOMETER ARK-1s
This recall has been terminated (originally issued December 20, 2017).
- Company
- Nidek Inc
- Recall Initiated
- December 20, 2017
- Terminated
- March 18, 2019
- Recall Number
- Z-1348-2018
- Quantity
- 63 untis
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
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.
Root Cause
Equipment maintenance
Action Taken
Customers were notified via letter on about 12/20/2017. The letter instructed consignees that a representative from Marco Ophthalmic, Inc. will make arrangements for the affected unit to be picked up and replaced with an ARK-S unit that meets factory specifications.