BEUDAMED
    FDA Enforcement Class II Terminated

    Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)

    Recall: Z-0932-2014 · Reported February 12, 2014

    Enforcement

    Recall Number
    Z-0932-2014
    Event ID
    67167
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2014
    Initiation Date
    December 4, 2013
    Classification Date
    February 4, 2014
    Termination Date
    February 2, 2016
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131, United States

    Description

    Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)

    Reason

    The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.

    Code Info

    Model #882412; Serial #'s:14701, 14702, 14704, 14705, 14706, 14707, 14708, 14709, 14710 & 14711. Model #882438; Serial #'s:17002, 17003, 17004, 17005, 17006, 17007, 17008, 17009, 17010, 17011, 17012, 17013, 17014, 17015, 17017, 17018, 17019, 17021, 17022, 17023, 17024, 17025, 17026 & 17028. Model #882470; Serial #'s: 7003, 7004, 7005, 7006, 7008, 7009, 7010, 7011, 7014, 7015, 7017, 7019, 7020, 7021, 7022, 7024, 7025, 7026, 7031, 7034, 7035, 7036, 7039, 7043, 7045, 7049, 7050, 7052, 7053, 7054, 7058, 7060, 7062, 7064, 7066, 7068, 7069, 7074, 7075, 7077, 7080, 7081, 7084, 7085, 7086, 7087, 7089, 7093, 7094, 7095, 7096, 7097, 7098, 7099, 7108, 7112, 7114, 7115, 7118, 7120, 7121, 7122, 7123, 7124, 7125, 7128, 7129, 7131, 7135, 7137, 7138, 7139, 7140, 7142, 7143, 7145, 7147, 7148, 7156, 7159, 7161, 7163, 7166, 7168, 7173, 7174, 7176, 7177, 7181, 7183, 7184, 7185, 7186, 7187, 7193, 7194, 7195, 7196, 7197, 7198, 7199, 7200, 7207, 7208, 7210, 7211, 7215, 7216, 7223, 7224, 7226, 7228, 7230, 7233, 7235, 7239, 7240, 7242, 7501, 7503, 7507, 7508, 7511, 7514, 7517, 7518, 7520, 7521, 7523, 7527, 7528, 7529, 7530, 7531, 7532, 7533, 7536, 7538, 7540, 7545, 7546, 7554, 7559, 7564, 7566, 7568, 7570, 7573, 7581, 7583, 7584, 7586, 7590, 7591, 7104M, 7106M, 7170M &7582M. Model #882471; Serial #'s: 7007, 7012, 7013, 7016, 7027, 7028, 7029, 7030, 7032, 7037, 7042, 7044, 7048, 7055, 7057, 7059, 7061, 7063, 7065, 7071, 7072, 7076, 7078, 7079, 7082, 7083, 7088, 7091, 7092, 7102, 7103, 7105, 7116, 7117, 7119, 7126, 7132, 7136, 7141, 7144, 7146, 7149, 7152, 7153, 7154, 7158, 7160, 7164, 7167, 7169, 7171, 7172, 7175, 7178, 7179, 7180, 7182, 7188, 7189, 7190, 7192, 7201, 7202, 7203, 7204, 7205, 7206, 7209, 7212, 7213, 7214, 7217, 7218, 7219, 7221, 7227, 7229, 7231, 7234, 7236, 7238, 7241, 7245, 7251, 7252, 7253, 7254, 7255, 7256, 7257, 7258, 7504, 7506, 7509, 7510, 7512, 7515, 7516, 7519, 7524, 7525, 7535, 7537, 7539, 7542, 7543, 7544, 7548, 7549, 7550, 7552, 7553, 7555, 7556, 7557, 7558, 7560, 7561, 7562, 7563, 7567, 7569, 7572, 7574, 7575, 7577, 7578, 7579, 7585, 7587, 7589 &7592. Model #882473; Serial #'s: 7040, 7048, 7070, 7095, 7111, 7113, 7127, 7130, 7134, 7150, 7151, 7155, 7157, 7162, 7237 & 7249. Model #:882476; Serial #'s: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226, 9228, 9229 & 9231.

    Distribution

    Product was shipped to the following states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, NY , OH, OR, PA, TN, TX, VA, VT, WA & WI. Product was also shipped to the following countries: Australia, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Cuba, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlands, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Russia, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Ukraine, United Kingdom, Venezuela & Vietnam.

    Quantity

    386 units