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Sonogage Inc recalls Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye le
Recalled September 25, 2013 · FDA recall Z-2202-2013 · Sonogage
Hazard
During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device. · FDA Class II
Units
564 units
Sold at
Worldwide Distribution - USA Nationwide in the following states: AK, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MN, NE, NJ, NM, NY, OH, OR, PA, TX, VA and WA. Product was also shipped to Canada and Mexico.
Description
During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.
Product
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
Manufacturer(s)
Sonogage Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →