Recall Z-2202-2013— Sonogage Inc
Class II · Terminated
Class II FDA medical device recall by Sonogage Inc, initiated 2013-08-09, terminated 2015-09-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.. 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..
- Recalling firm
- Sonogage Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-09
- Terminated
- 2015-09-19
- Firm location
- Cleveland, OH, United States
Product description
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.