BEUDAMED
    FDA Recall Terminated

    LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi -Access OIS for Siemens. An oncology digital imaging information management system. Lantis OIS in combination with Sequencer and a non-Siemens linac interface. System components include: LANTIS Commander, LANTIS system, LANTIS 6.1 Commander, LANTIS 8.3 Commander. Subcomponents include: Linac Interface, other vendor, LANTIS Varian Clinac, LANTIS GE Saturn, LANTIS Philips SLS, LANTIS Philips 75 ASU, LANTIS Elekta (Philips) and LANTIS Varian EX I/F.

    Recall: Z-2983-2011 · Initiated June 30, 2011

    Recall

    Recall Number
    Z-2983-2011
    Event Number
    59347
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 30, 2011
    Posted
    August 10, 2011
    Terminated
    March 9, 2012
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi -Access OIS for Siemens. An oncology digital imaging information management system. Lantis OIS in combination with Sequencer and a non-Siemens linac interface. System components include: LANTIS Commander, LANTIS system, LANTIS 6.1 Commander, LANTIS 8.3 Commander. Subcomponents include: Linac Interface, other vendor, LANTIS Varian Clinac, LANTIS GE Saturn, LANTIS Philips SLS, LANTIS Philips 75 ASU, LANTIS Elekta (Philips) and LANTIS Varian EX I/F.

    Reason

    A potential safety issue exists for data transfer between LANTIS OIS system (containing PRIMEVIEW or PRIMEVIEW Data Gateway) and the Sequencer V&R system via a third party interface is used.

    Action

    Siemens sent an "Update Instructions/Customer Safety Advisory Notice" to all affected users, beginning June 30, 2011. The letter includes description of the product and problem and provides updated instructions to ensure data is stored in the system. If you have questions contact Siemens at (925) 602-8157.

    Distribution

    Worldwide Distribution: Nationwide (USA) including the states of MI, DE, WI, FL, CA, TN, NJ, PA, NE, IL, WV , MA and VA; and the countries of Poland, France, Germany, Canada, Netherlands, India, Ireland, Egypt, P.R. china, Australia, Saudi Arabia, Turkey, Republic Korea, Belgium, Hungary, New Zealand, Italy, Malaysia, and Spain.

    Quantity

    59 devices