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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length. 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. Class II During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device. 564 units Z-2202-2013
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