Device product
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)
Z-0932-2014
Product summary
- Event
- Event 67167
- Status
- Terminated
- Classification
- Class II
- Quantity
- 386 units
- Official record key
device-enforcement:Z-0932-2014
Official wording
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 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.
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.