Events

Recall of Sienet Sky

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
    36529
  • Event Risk Class
    Class 2
  • Event Number
    Z-0071-2007
  • Event Initiated Date
    2006-09-05
  • Event Date Posted
    2006-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48861
  • 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
    image archive system - Product Code LLZ
  • Reason
    Potential issue with annotation function. annotations, shown as overlays, may change font size when the image is saved. text may appear shifted, or lines appear thicker, and their position may not be as intended.
  • Action
    The recalling firm has issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions HS096/06/S and HS097/06/S. The letter, dated September 5, 2006, informs customers of this issue and provides recommendations to avoid its occurrence.

Device

Sienet Sky
  • Model / Serial
    Model number 8463163, all versions.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities nationwide.
  • Product Description
    Sienet Sky, picture archiving and communications system. Model number 8463163
  • 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