Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF P...
FDA Recall #Z-0932-2014 — Class II — December 4, 2013
Product 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 for Recall
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.
Recalling Firm
Philips Medical Systems (Cleveland) Inc — Cleveland, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
386 units
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.
Code Information
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.