Recall Z-2202-2013 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Sonogage Inc
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
| Date | Sep 16, 2013 (initiated Aug 9, 2013) |
| Status | Terminated |
| Reason | During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device. |
| Root cause | No Marketing Application |
| 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. |
| Quantity | 564 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.