Events

Recall of Device Recall Aplio 80

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Medical Systems 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
    52832
  • Event Risk Class
    Class 2
  • Event Number
    Z-1172-2010
  • Event Initiated Date
    2007-11-12
  • Event Date Posted
    2010-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84101
  • 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
    Ultrasonic Pulsed Doppler Imaging System - Product Code IYN
  • Reason
    Toshiba america medical system inc initiated a field corrective action on aplio 50; ssa-700a; software version 5.5r002 and later, aplio 80; ssa-700a; software version 5.5r002 and later, and xario; ssa-660a; software version 1.0 and later, because the product does not meet the safety standard requirements.
  • Action
    Toshiba America Medical Systems (TAMS) has issued a Field Modification Instruction notification to all of its customers about the affected devices. The correct software will be administered through TAMS' representatives. Reimbursement for the modification will be given upon receipt of the reimbursement claim invoice.

Device

Device Recall Aplio 80
  • Model / Serial
    F4603656, F4603654, F4613731, F5513813, F4613730, F4613732, G5523875, G5523871, A2542234, F4603309, F450331, F4603314, F4603317, D3622941, F4603315, F4623389, F4613351, F4613356, F4613352, F4613353, F5513467, F4613339, F5513458, F5513433, F5513448, F5513452, F5513431, F5513439, F4613344, F5513455, F4623391, F5513464, F4623378, F4313338, F4613341, F4613343, F5513437, F5513451, F5513469, 5F513450, F4623379, F4623388, F4623375, F4623383, F5513446, F4623392, F5513449, F4613337, F4623381, F4623377, F5513460, F4623380, F4613342, F5513430, F5513463, F5513445, F4623390, F5513461, F5513462, F5513432, 80G0543639, 80G0543628, 80G0593786, G5523558, 80G0543644, 80G0543643, G5523519, G5523536, G5523544, 80G0523567, 80G0593789, 80G0593774, G5523513, G5523514, G5523564, G5523563, 80G0543637, G5523562, 80G0583731, 80G0593794, 80G0583728, 80G0593790, 80G0593791, 80G0593773, 80G0543640, 80G0593793, 80G0523565, 80G0543636, 80G0543645, G5523538, 80G0543627, 80G0583730, 80G0593792, G5523559, 80G0543625, G5523539, G5523541, G5523537, 80G0583727, 80G0593785, 80G0593802, and  80G0593803.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Aplio 80; SSA-770A; software version 5.5r002
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Manufacturer Address
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA