RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical
FDA device recall Z-1245-2016 · posted 2016-03-24 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- Reason for recall
- There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient.
- Action taken
- Nidek sent a Recall letters dated February 29, 2016 to all affected site. The letter identified the affected product, problem and actions to be taken. Nidek Customer Service will be replacing the affected product with new parts to address this recall. For questions call Customer Service at 1-800-722-0219.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HKN
- Quantity affected
- 2703 separate serial numbers
- Distribution
- US Nationwide Distribution
- Date initiated
- 2016-02-29
- Date posted
- 2016-03-24
- Date terminated
- 2018-09-24
- Location
- Fremont, CA
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