Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
FDA Recall Z-2202-2013 · Posted 2013-09-16
Recalling FirmSonogage Inc
Recall StatusTerminated
Product CodeIYO
Date Initiated2013-08-09
Date Terminated2015-09-19
Product Quantity564 units
Reason for Recall
During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.
Firm Action
Sonogage sent an Urgent: Medical Device Recall letter dated August 9, 2013 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine inventory and quarantine the affected product for return. Customers were asked to complete and return the enclosed response form. For question call 216-464-1119 or 800-798-1119.
Root Cause
No Marketing Application
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.