Events

Recall of Syngo Imaging XS

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
    53563
  • Event Risk Class
    Class 2
  • Event Number
    Z-0270-2010
  • Event Date Posted
    2009-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85875
  • 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
    Picture archiving and communications system - Product Code LLZ
  • Reason
    Distorted image. the "distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another source.
  • Action
    The recalling firm issued a Customer Safety Advisory notice dated 9/14/09 to all affected customers via Update Instructions IM100/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. To avoid the potential risk of the issue, the local compression function can be disabled as described in the letter. Depending on the image data, the disabling of compression will result in increased storage usage. The issue will be resolved in the release of version VA70B. For all potentially affected customers with "JPEG Compression" license an update instruction will be released which defines the necessary corrective actions in case of "Distorted" images. The update instruction will be performed on request by the customer service group. Further questions regarding this issue are directed to the local SIEMENS Uptime Service Center or +49 (9131) 84-2056.

Device

Syngo Imaging XS
  • Model / Serial
    Model number 7502029 - Serial numbers: 9620, 9621, 9622, 9623, 9624, 9625, 9630, 9631, 9632, 9633, 9634, 9639, 9640, 12068, 12271, 13090, 13358, 13428, 13480, 13637, 13727, 13742, 13945, 13971, 13979, 14059, 14086, and 14960.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities in CA, FL, GA, IL, MD, MI, MO, NE, NC, NY, OH, PA, TN, TX, and WV.
  • Product Description
    Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA