Events

Recall of SERVER SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    32765
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-14
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A potential issue when using "in-progress" invasive reporting with sensis integration to syngo dynamics v9.5. the issue occurs under the following conditions: - sensis-syngo dynamics integration - sensis study is opened from syngo dynamics while still "in-progress" - sensis reference numbers > 1000000 -sensis reference numbers grow in response to hl7 messages even if those hl7 messages are not being utilized by sensis and/or syngo dynamics. sensis reference number greater than 1000000 are wrongly modified during transfer to syngo dynamics. when this happens during "in-progress" reporting a study will get a sensis reference number for the wrong study in sensis. this causes an incorrect 'link' between the syngo dynamics images and the sensis study data. if this happens customers will have to call siemens service team. there has not been any patient consequence reported from the installed base.

Device

SERVER SOFTWARE
  • Model / Serial
    Model Catalog: 10091862 (Lot serial: S/N 85162); Model Catalog: 10091863 (Lot serial: S/N 85182)
  • Product Description
    SERVER SOFTWARE
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC