Events

Recall of Sienet Cosmos

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
    36527
  • Event Risk Class
    Class 2
  • Event Number
    Z-0069-2007
  • Event Initiated Date
    2006-10-03
  • Event Date Posted
    2006-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48854
  • 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 archiving and communications system - Product Code LLZ
  • Reason
    Potential loss of images. images may not successfully be sent to the raid system.
  • Action
    The recalling firm has issued a software patch to resolve the issue via Update Instructions HS110/06/S. The Update Instructions direct a Siemens Service Representative to visit the affected sites, install the software patch to resolve the issue, and hand deliver a Customer Advisory Notice, dated September 20th, 2006, to the customer to notify them of the issue.

Device

Sienet Cosmos
  • Model / Serial
    Model number 10018969. Serial numbers 1001, 1010, 1011, 1028, 1029
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to hospitals in CA, MD, MO, and PA
  • Product Description
    Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969
  • 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