Reported Sep 25, 2013 · Terminated
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
Sonogage Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sonogage Inc · 26650 Renaissance Pkwy · Cleveland, OH · 44128-5776
Is this the product you have?
- Sonogage EyeScan, A-Scan Biometer
- Product UsageA-Scan Biometer diagnostic device for measurement of axial eye length
- Lot codes and dates
Serial #: ES10001 - ES10002ES10004 -ES10012ES10014 - ES10040ES10042 - ES100167ES10170-ES10185ES10187 - ES10214ES10218 - ES10224ES10226ES10228 - ES10230ES10233ES10235-ES10242ES10244 - ES10252ES1024-ES10426ES10253 - ES10260ES10262ES10267 - ES10277ES10279 - ES10306ES10308 - ES10347ES10349-ES10357ES10359 - ES10423ES10427 - ES10444ES10446 - ES10472ES10474ES10476 - ES10478ES10481 - ES10483ES10485 - ES10508ES10510ES10512 - ES10529ES10531 - ES10543ES10545 - ES10546ES10548 - ES10558ES10560 - ES10566ES10568 - ES10570ES1059T10217 & T80002-T80020
- Amount recalled
- 564 units
Where it was sold
Why it was recalled
During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.
This product could cause temporary or reversible health problems — stop using it.
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