BEUDAMED
    FDA Enforcement Class II Terminated

    Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.

    Recall: Z-1217-2015 · Reported March 11, 2015

    Enforcement

    Recall Number
    Z-1217-2015
    Event ID
    69970
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arjo Hospital Equipment AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2015
    Initiation Date
    December 3, 2014
    Classification Date
    February 27, 2015
    Termination Date
    October 30, 2015
    Address
    HANS MICHELSENSGATAN 10, N/A, Malm¿, N/A, N/A, Sweden

    Description

    Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.

    Reason

    The recalled devices labeling and instructions for use contain unapproved medical claims.

    Code Info

    SERIAL NUMBERS: RRFK00041, RRFK00083, RRFK00232, RRFK00233, RRFK00276, RRFK00229, RRFK00215, RRFK00221, RRFK00243, RRFK00121, RRFK00263, RRFK00094, RRFK00150, RRFK00274, RRFK00103, RRFK00198, RRFK00256, RRFK00111, RRFK00290, RRFK00091, RRFK00044, RRFK00087, RRFK00241, RRFK00047, RRFK00186, RRFK00059, RRFK00170, RRFK00246, RRFK00064, RRFK00071, RRFK00289, RRFK00056, RRFK00078, RRFK00178, RRFK00051, RRFK00248, RRFK00155, RRFK00202, RRFK00247, RRFK00128, RRFK00228, RRFK00269, RRFK00126, RRFK00277, RRFK00207, RRFK00253, RRFK00067, RRFK00280, RRFK00108, RRFK00174, RRFK00161, RRFK00105, RRFK00125, RRFK00240, RRFK00052, RRFK00102, RRFK00147, RRFK00153, RRFK00082, RRFK00062, RRFK00225, RRFK00265, RRFK00070, RRFK00104, RRFK00123, RRFK00172, RRFK00085, RRFK00069, RRFK00190, RRFK00252, RRFK00287, RRFK00050, RRFK00119, RRFK00210, RRFK00239, RRFK00169, RRFK00191, RRFK00149, RRFK00168, RRFK00162, RRFK00226, RRFK00068, RRFK00284, RRFK00107, RRFK00227, RRFK00049, RRFK00166, RRFK00194, RRFK00196, RRFK00216, RRFK00148, RRFK00230, RRFK00266, RRFK00143, RRFK00097, RRFK00199, RRFK00223, RRFK00188, RRFK00101, RRFK00164, RRFK00037, RRFK00167, RRFK00192, RRFK00055, RRFK00086, RRFK00173, RRFK00177, RRFK00222, RRFK00238, RRFK00189, RRFK00038, RRFK00165, RRFK00099, RRFK00160, RRFK00141, RRFK00201, RRFK00043, RRFK00080, RRFK00112, RRFK00209, RRFK00124, RRFK00146, RRFK00042, RRFK00066, RRFK00184, RRFK00106, RRFK00224, RRFK00275, RRFK00180, RRFK00115, RRFK00251, RRFK00278, RRFK00237, RRFK00283, RRFK00219, RRFK00254, RRFK00179, RRFK00211, RRFK00127, RRFK00117, RRFK00157, RRFK00120, RRFK00073, RRFK00193, RRFK00195, RRFK00218, RRFK00096, RRFK00095, RRFK00204, RRFK00053, RRFK00282, RRFK00113, RRFK00200, RRFK00264, RRFK00118, RRFK00109, RRFK00122, RRFK00261, RRFK00244, RRFK00187, RRFK00039, RRFK00152, RRFK00181, RRFK00206, RRFK00231, RRFK00046, RRFK00093, RRFK00159, RRFK00088, RRFK00154, RRFK00076, RRFK00145, RRFK00175, RRFK00270, RRFK00065, RRFK00089, RRFK00054, RRFK00213, RRFK00040, RRFK00057, RRFK00156, RRFK00144, RRFK00249, RRFK00258, RRFK00045, RRFK00092, RRFK00176, RRFK00142, RRFK00036, RRFK00242, RRFK00151, RRFK00183, RRFK00060, RRFK00257, RRFK00061, RRFK00074, RRFK00217, RRFK00273, RRFK00171, RRFK00250, RRFK00158, RRFK00220, RRFK00163, RRFK00208, RRFK00279, RRFK00205, RRFK00098, RRFK00288, RRFK00063, RRFK00110, RRFK00072, RRFK00235, RRFK00267, RRFK00077, RRFK00079, RRFK00081, RRFK00182, RRFK00090, RRFK00197, RRFK00214, RRFK00084, RRFK00100, RRFK00245, RRFK00075, RRFK00114, RRFK00260

    Distribution

    Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.

    Quantity

    226 units