BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0053-04 · Initiated September 5, 2003

    Recall

    Recall Number
    Z-0053-04
    Event Number
    27105
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    1000514697
    Product Code
    KPS--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 5, 2003
    Posted
    October 24, 2003
    Terminated
    February 24, 2005
    Address
    2501 N. Barrington Road, Hoffman Estates, IL, 60195-5203

    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

    Reason

    The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator.

    Action

    Siemens sent Important Safety Customer Advisory letters dated 8/27/03 to all e.cam customers on 9/5-12/03. The accounts were informed of the problem with the detector''s radial brake not being applied properly, allowing slow, unintended downward motion of the detector that could result in injury to the patient or operator, and were advised not to leave the patient unattended while on the pallet and not to leave the patient under the detector upon completion of the study. The customers were advised that they would be contacted by their Siemens service provider to schedule a mandatory update to the e.cam to correct the problem. The upgrade will be done free of charge.

    Distribution

    Nationwide, United Arab Emirates, Albania, Argentina, Austria, Australia, Bosnia, Barbados, Bangladesh, Belgium, Bolivia, Brazil, Cameroon, Canada, Chile, China, Colombia, Republic of Congo, Costa Rica, Czech Republic, Denmark, Dominican Republic, El Salvador, Ecuador, Egypt, France, Finland, Germany, Great Britain, Georgia, Greece, Hong Kong, Honduras, Ireland, India, Italy, Iran, Iraq, Jordan, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Mexico, Morocco, Macedonia, Madagascar, Myanmar, Mauritius, Malaysia, Nepal, Norway, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, Ukraine, Uzbekistan, Zimbabwe, South Africa and the Netherlands.

    Quantity

    2,386 units