Events

Recall of Device Recall e.cam

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
    25546
  • Event Risk Class
    Class 2
  • Event Number
    Z-0623-03
  • Event Initiated Date
    2003-02-10
  • Event Date Posted
    2003-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26012
  • 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, Tomography, Computed, Emission - Product Code KPS
  • Reason
    Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions.
  • Action
    Siemens sent Customer Advisory letters dated 2/10/03 to all e.cam customers. The accounts were informed of the problem with unexpected camera movement when multiple fault cocnditions are presnet, causing the brake system to release and the roation of the detector assemblies, and were advised to use the emergency stop at any indication of improper camera movement. The customers were advised that they would be contacted by their Siemens Customer Service Representative to schedule a firmware upgrade that will prevent the occurrence of unintended release of the radial and rotate brakes. The upgrade will be done free of charge.

Device

Device Recall e.cam
  • Model / Serial
    All e.cam towers, serial numbers 00013 through 08543, utilizing e.soft, ICON-S and duet acquisition systems, and e.soft and ICON-S COIN systems.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, United Arab Emirates, Argentina, Austria, Australia, Bosnia, Barbados, Bangladesh, Belgium, Bolivia, Brazil, Camaroon, Canada, Chile, China, Colombia, Republic of Congo, Czech Republic, Denmark, Dominican Republic, El Salvador, Equador, Egypt, France, Finland, Germany, Great Britain, Georgia, Greece, Hong Kong, Honduras, Ireland, Israel, India, Italy, Iraq, Jordan, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Mexico, Morocco, Madagascar, Myanmar, Mauritius, Malaysia, Niger, Norway, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Potugal, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, Uzbekistan, South Africa and the Netherlands.
  • Product Description
    e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., || Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 2501 N. Barrington Road, Hoffman Estates IL 60195-5203
  • Source
    USFDA