OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11
FDA device recall Z-2477-2015 · posted 2015-08-27 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- Reason for recall
- Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations.
- Action taken
- Dear Doctor letters mailing started on July 15, 2015 - first 100. They will be mailed out as the correction is received from Nidek, Japan. Dear Doctor letter will include software upgrade kit including CD or USB, instruction for upgrade and pre-paid response card to be returned to Nidek Inc.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HKO
- Quantity affected
- 3836
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-06-15
- Date posted
- 2015-08-27
- Date terminated
- 2016-04-25
- Location
- Fremont, CA
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