RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan.
FDA device recall Z-1853-2014 · posted 2014-06-23 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- Reason for recall
- Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
- Action taken
- 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
- Root cause
- Use error
- Status
- Terminated
- Product code
- HKN
- Quantity affected
- ~4,285 units RT-5100; 167 units of RT-3100
- Distribution
- US distribution only.
- Date initiated
- 2014-06-09
- Date posted
- 2014-06-23
- Date terminated
- 2015-10-30
- Location
- Fremont, CA
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