Events

Recall of Device Recall Aplio XG model SSA790A

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
    55941
  • Event Risk Class
    Class 2
  • Event Number
    Z-2981-2011
  • Event Initiated Date
    2010-06-02
  • Event Date Posted
    2011-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92271
  • 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
    Toshiba america medical systems inc (tams) is initiating a field correction on the the aplio xg model ssa-790a because it did not meet the requirement of clause 15b, iec60601-1 which requires that the residual voltage shall not exceed 60v after 1 second from taking off the ac plug.
  • Action
    Toshiba America Medical Systems (TAMS) sent an "URGENT:MEDICAL DEVICE CORRECTION' letter dated June 2, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to be careful not to touch the contacts or prongs on the AC plug within two seconds after unplugging the system from a wall socket. This precaution is to be adhered to until a Toshiba Service Representative replaces the power supply. Customers are to complete and return a Customer Reply Form and fax to 877-349-3054. Customers with questions regarding the notification should contact the Director of Regulatory Affairs at (800) 421-1968 or call their local Toshiba Representative at (800) 521-1968.

Device

Device Recall Aplio XG model SSA790A
  • Model / Serial
    4899 5131, 5132, 5133, 5134, 5224, 5139, 5260, 5261, 5369, 5256, 5367, 4883, 4884, 5370, 5374, 5375, 5264, 5257, 5135, 5223, 5379, 5262, 6283, 4886, 5258, 5382, 5383, 5384, 5385, 5216, 4887, 4897, 4898, 5027, 5380, 4982, 5026, 5137, 5138, 5219, 5220, 4979, 5465, 4900, 5466, 4978, 5377, 5136, 5376, 5072, 5071, 5221, 5215, 4981, 5371, 5372, 5373, 5029, 5030, 5068, 5069, 5070, 5222, 4980, 4885, 5259, 5028, 4896, 5368, 5217, 5218, 5140, 5265, 5364, 5365, 5366, 5381, 5467, 5468, 5469, 5470, 5471, 5472, 5473, 5474
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Aplio XG model SSA-790A || Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound system incorporating state-of-the-art technologies. It is provided with the highest level of image quality and operability (reflecting the XG (next Generation) in its name), and can be used with ease for research as well as for routine clinical studies.
  • 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