Z-2477-2015 Class II Terminated
FDA device recall Z-2477-2015 was initiated by Nidek Inc on June 15, 2015 and is designated Class II. 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. The recall status is terminated (terminated April 25, 2016). Affected quantity: 3836.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2015
- Initiation Date
- June 15, 2015
- Termination Date
- April 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3836
Product Description
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 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.
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.
Distribution Pattern
Nationwide Distribution.
Code Information
Software versions: 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01.