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U.S. Department of Health and Human Services

Class 2 Device Recall RT5100 Refractor and RT3100 Refractor

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  Class 2 Device Recall RT5100 Refractor and RT3100 Refractor see related information
Date Initiated by Firm June 09, 2014
Date Posted June 23, 2014
Recall Status1 Terminated 3 on October 30, 2015
Recall Number Z-1853-2014
Recall Event ID 68485
Product Classification Refractor, manual, non-powered, including phoropter - Product Code HKN
Product 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.
Code Information RT-5100 and RT-3100, various serial numbers.
Recalling Firm/
Manufacturer		 Nidek Inc
47651 Westinghouse Dr
Fremont CA 94539-7474
For Additional Information Contact Neo Yamaguchi
510-353-7785
Manufacturer Reason
for Recall		 Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
FDA Determined
Cause 2		 Use error
Action Recall/Field Correction letters were sent to doctors on June 9, 2014 with a preventive maintenance instruction to be performed on the device by user. Also included are the necessary tools to perform actions. Customers are to complete and return the Recall Response Card. Questions are to be directed to Customer Service. Contact Information: Customer Service: 1-800-891-1772 E-mail: RT-5100 update@noritsu.com
Quantity in Commerce ~4,285 units RT-5100; 167 units of RT-3100
Distribution US distribution only.
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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