Recall Z-1348-2018 ยท HKO Refractometer, Ophthalmic
Nidek Inc.
AUTO REF/KERATOMETER ARK-1s
| Date | Dec 20, 2017 |
| Status | Terminated |
| Reason | There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.