Events

Recall of AScan Biometer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sonogage Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66027
  • Event Risk Class
    Class 2
  • Event Number
    Z-2202-2013
  • Event Initiated Date
    2013-08-09
  • Event Date Posted
    2013-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121290
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Reason
    During an fda inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.
  • 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.

Device

AScan Biometer
  • Model / Serial
    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 Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Sonogage EyeScan, A-Scan Biometer, || Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
  • Manufacturer
    Sonogage Inc

Manufacturer

Sonogage Inc
  • Manufacturer Address
    Sonogage Inc, 26650 Renaissance Pkwy, Cleveland OH 44128-5776
  • Manufacturer Parent Company (2017)
    Sonogage Inc
  • Source
    USFDA