Events

Recall of Syngo MultiModality WorkPlace

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
    50085
  • Event Risk Class
    Class 2
  • Event Number
    Z-0324-2009
  • Event Initiated Date
    2008-09-12
  • Event Date Posted
    2008-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74696
  • 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
    Radiological image processing system - Product Code LLZ
  • Reason
    Values derived from dynamic ct data sets may be incorrect. the corresponding images are not affected.
  • Action
    The recalling firm has issued a software update to affected customers via Update Instructions CT034/08/S. This software update corrects the values from the volume perfusion post processing application. A firm representative will visit each consignee to install the software update beginning 9/12/08.

Device

Syngo MultiModality WorkPlace
  • Model / Serial
    Serial numbers: 7826, 7951, 7981, 7989, 8011, 8056, 8109, 8161, 8209, 8213, 8312, 8341, 8361, 8382, 8393, 8405, 8409, 8413, 8430, 8433, 8442, 8511, 8526, 8536, 8548, 8637, 8638, 8657, 8670, 8688, 8701, 8707, 8771, 8772, 8773, 8774, 8781, 8793, 8814, 8829, 8862, 8879, 8881, 9043, 9044, 9046, 9080, 9097, 9081, 9105, 9137, 9149, 9152, 9154, 9188, 9191, 9206, 9218, 9219, 9232, 9235, 9243, 9244, 9248, 9283, 9291, 9316, 9322, 9351, 9360, 9361, 9368, 9388, 9394, 9395, 9413, 9414, 9416, 9417, 9429, 9445, 9446, 9452, 9488, 9498, 9504, 9508, 9520, 9521, 9532, 9536, 9568, 9723, 9725, 9729, 9737, 15154, 15510, 15512, 20903, 20904, 20907, 20917, 20928, 20931, 20937, 20939, 20940, 20941, 20942, 20943, 20944, 20945, 20946, 20948, 20955, 20956, 20957, 20961, 20962, 20972, 20974, 20977, 21017, 21018, 21020, 21021, 21025, 21028, and 21030.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). || The product is intended for use in picture archiving and communications system.
  • 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 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA