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U.S. Department of Health and Human Services

Class 2 Device Recall AScan Biometer

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 Class 2 Recall
AScan Biometer
see related information
Date Posted September 16, 2013
Recall Status1 Open
Recall Number Z-2202-2013
Recall Event ID 66027
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - Product Code IYO
Product Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
Code Information Serial #: ES10001 - ES10002, ES10004 -ES10012, ES10014 - ES10040, ES10042 - ES100167, ES10170-ES10185, ES10187 - ES10214, ES10218 - ES10224, ES10226, ES10228 - ES10230, ES10233, ES10235-ES10242, ES10244 - ES10252, ES1024-ES10426, ES10253 - ES10260, ES10262, ES10267 - ES10277, ES10279 - ES10306, ES10308 - ES10347, ES10349-ES10357, ES10359 - ES10423, ES10427 - ES10444, ES10446 - ES10472, ES10474, ES10476 - ES10478, ES10481 - ES10483, ES10485 - ES10508, ES10510, ES10512 - ES10529, ES10531 - ES10543, ES10545 - ES10546, ES10548 - ES10558, ES10560 - ES10566, ES10568 - ES10570, ES1059, T10217 & T80002-T80020.
Recalling Firm/
Manufacturer
Sonogage Inc
26650 Renaissance Pkwy
Cleveland, Ohio 44128-5776
Manufacturer 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.
FDA Determined
Cause 2
PREMARKET APPROVAL: 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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