Events

Recall of Device Recall Picture Archiving and Communication System

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
    73475
  • Event Risk Class
    Class 2
  • Event Number
    Z-1349-2016
  • Event Initiated Date
    2016-01-18
  • Event Date Posted
    2016-04-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144261
  • 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
    To inform users about the possible incorrect values for distance measurements when using certain modalities in combination with syngo imaging.
  • Action
    Siemens mailed a Customer Advisory Notice to their customers instructing them to check their modalities for the usage of the mentioned DICOM attributes with different values. They recommended upgrading the workplace(s) to syngo Imaging Studio version VB36D if they have such modalities and it cannot be ensured by the modality provider that only one attribute is filled or both attributes are filled with the same value. Customers were asked to contact their local service organization to clarify the compatibility of their syngo Imaging server version with workplace version VB36D.

Device

Device Recall Picture Archiving and Communication System
  • Model / Serial
    Model # 10014063
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI.
  • Product Description
    A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography 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