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Class 2 Device Recall AScan Biometer |
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Date Initiated by Firm |
August 09, 2013 |
Date Posted |
September 16, 2013 |
Recall Status1 |
Terminated 3 on September 19, 2015 |
Recall Number |
Z-2202-2013 |
Recall Event ID |
66027 |
Product Classification |
System, imaging, pulsed echo, ultrasonic - Product Code IYO
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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 OH 44128-5776
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For Additional Information Contact |
216-464-1119
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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