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U.S. Department of Health and Human Services

Class 2 Device Recall GEMINI LXL GEMINI TF PET/CT16 GEMINI TF PET/CT 64

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 Class 2 Recall
GEMINI LXL GEMINI TF PET/CT16 GEMINI TF PET/CT 64
see related information
Date Posted February 04, 2014
Recall Status1 Open
Recall Number Z-0932-2014
Recall Event ID 67167
Premarket Notification
510(K) Number
K052640 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
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)
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.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland, Ohio 44143-2131
For Additional Information Contact Mrs. Kumudini J. Carter
440-483-3032
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
Action On 12/4/2013, the firm sent Field Safety Noticies to their customers.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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