Sonogage EyeScan A-Scan Biometer Recalled for Lack of FDA Clearance
Sonogage Inc is recalling 564 EyeScan A-Scan Biometers because the firm lacked FDA registration and 510(k) clearance for the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is a lack of registration and clearance rather than a physical defect or reported illness, fitting the criteria for a voluntary precautionary recall or minor regulatory issue.
Plain-English summary
Sonogage Inc is recalling 564 units of the EyeScan A-Scan Biometer, a diagnostic device used to measure axial eye length. The recall was initiated after an FDA inspection conducted from July 15 to July 26, 2013, revealed that the firm lacked the required FDA registration and 510(k) clearance for the device.
The affected devices were distributed worldwide, including nationwide in the United States and in Canada and Mexico. Specific serial numbers are listed in the official recall notice. No illnesses or injuries have been reported in connection with this recall.
Consumers and healthcare providers who possess these devices should stop using them and contact Sonogage Inc for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
- Manufacturer
- Sonogage Inc
- Affected units
- 564
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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