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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
Recall Number Z-2202-2013
Classification Class II
Code Info 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.
Product Distributed Qty 564 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.

Event Detail

Event Id 66027
Product Type Devices
Status Ongoing
Recalling Firm Sonogage Inc
City Cleveland
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-09
Initial Firm Notification of Consignee or Public Letter
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; and countries of Canada and Mexico.