Events

Recall of Device Recall Syngo.via

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, 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
    74620
  • Event Risk Class
    Class 2
  • Event Number
    Z-2245-2016
  • Event Initiated Date
    2016-06-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148056
  • 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, image processing, radiological - Product Code LLZ
  • Reason
    Incorrect values for the volume calculation. software update vb30b via update instructions sy018/16/p to resolve software errors.
  • Action
    Siemens released and mailed to customers a notice with software update VB30B instructions via update instruction SY018/16/P for customers to follow until the update can be made. The letter also described the software issues involved; and asked customers to include the letter in the operator's manual until the update is performed. Customers are to ensure that all necessary personnel are aware of the situation.

Device

Device Recall Syngo.via
  • Model / Serial
    310289,130542,130322,310149,130325,221063,310168,101762,221048,221096,220783,310195,130451,400031,130292,310114,220846,130269,130163,130402,130826,221051,102336,310282,220888,10007,221052,221049,130518,221002,221091,220915,130520,130472,100469,310249,130122,100013,130378,310188,102453,310079,310080,130240,130382,220985,310171,220879,220995, and 310268.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AR, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TX, and UT.
  • Product Description
    Syngo.via, picture archiving and communications system software controlled. || Intended to be used for viewing, manipulation, communication, and storage of medical images.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA