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U.S. Department of Health and Human Services

Class 2 Device Recall AUTO REF/KERATOMETER ARK1s

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  Class 2 Device Recall AUTO REF/KERATOMETER ARK1s see related information
Date Initiated by Firm December 20, 2017
Create Date April 10, 2018
Recall Status1 Terminated 3 on March 18, 2019
Recall Number Z-1348-2018
Recall Event ID 79553
Product Classification Refractometer, ophthalmic - Product Code HKO
Product AUTO REF/KERATOMETER ARK-1s
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.
Recalling Firm/
Manufacturer		 Nidek Inc.
47651 Westinghouse Dr
Fremont CA 94539-7474
For Additional Information Contact
800-223-9044
Manufacturer 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.
FDA Determined
Cause 2		 Equipment maintenance
Action 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.
Quantity in Commerce 63 untis
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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