Events

Recall of Device Recall syngo Dynamics

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
    65603
  • Event Risk Class
    Class 2
  • Event Number
    Z-1859-2013
  • Event Initiated Date
    2013-06-10
  • Event Date Posted
    2013-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119697
  • 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
    Siemens initiate this recall due to a potential issue when using the sdis matching rules of the syngo dynamics information system version 9.5 or va10a with modality device configured to end study at association close. images or dicom sr objects sent from a modality device to syngo dynamics may not be saved when the modality is configured at syngo dynamics to end study at association close, and whe.
  • Action
    Siemens sent a Customer Safety Advisory Notice dated June 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1) With sDIS implemented, use the DICOM Modality List (DMWL), without sDIS matching rules enabled OR 2) Do not implement sDIS. Update instructions were also provided. The reported issue will be resolved in a modification to syngo Dynamics version 9.5 and syngo Dynamics VA10A which will be released in the near future. We regret any inconvenience that this may cause , and we thank you in advance for your understanding. For further questions please call (610) 219-6300.

Device

Device Recall syngo Dynamics
  • Model / Serial
    Model Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX.
  • Product Description
    syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. || The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. || syngo¿ Dynamics is not intended to be used for reading mammography images.
  • 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