Philips Medical Systems recall: Software Issue
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray…
Why was Philips Medical Systems recalled?
Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Brilliance CT Big Bore - Model #728243 - Serial Numbers: 7006, 7007, 7008, 7009, 7013, 7014, 7015, 7016, 7017, 7018, 7019, 7020, 7021, 7022, 7023, 7024, 7025, 7026, 7027, 7028, 7029, 7030, 7031, 7032, 7033, 7034, 7035, 7036, 7037, 7038, 7039, 7040, 7041, 7042, 7043, 7044, 7045, 7046, 7047, 7048, 7049, 7050, 7051, 7053, 7054, 7055, 7056, 7057, 7058, 7059, 7060, 7061, 7062, 7063, 7064, 7065, 7066, 7067, 7068, 7069, 7070, 7071, 7072, 7073, 7074, 7075, 7076, 7077, 7078, 7079, 7080, 7081, 7082, 7083, 7084, 7085, 7086, 7087, 7088, 7089, 7090, 7091, 7092, 7093, 7094, 7095, 7096, 7097, 7098, 7099, 7100, 7101, 7102, 7103, 7104, 7105, 7106, 7107, 7108, 7109, 7110, 7111, 7112, 7113, 7114, 7115, 7116, 7117, 7118, 7119, 7120, 7122, 7123, 7124, 7125, 7126, 7127, 7128, 7129, 7130, 7131, 7132, 7133, 7134, 7135, 7136, 7137, 7138, 7139, 7140, 7141, 7142, 7143, 7144, 7145, 7146, 7147, 7148, 7149, 7150, 7151, 7152, 7153, 7154, 7156, 7157, 7158, 7159, 7160, 7161, 7162, 7163, 7164, 7165, 7166, 7167, 7168, 7169, 7170, 7171, 7173, 7174, 7175, 7177, 7178, 7179, 7181, 7183, 7184, 7185, 7186, 7187, 7188, 7189, 7191, 7192, 7193, 7194, 7195, 7196, 7197, 7198, 7199, 7201, 7202, 7203, 7204, 7205, 7206, 7207, 7208, 7209, 7210, 7211, 7212, 7213, 7214, 7215, 7216, 7217, 7218, 7219, 7220, 7221, 7222, 7223, 7224, 7225, 7226, 7227, 7228, 7229, 7230, 7231, 7232, 7233, 7234, 7235, 7236, 7237, 7238, 7239, 7240, 7241, 7242, 7243, 7245, 7246, 7247, 7248, 7249, 7250, 7251, 7253, 7254, 7255, 7256, 7257, 7258, 7259, 7260, 7261, 7262, 7263, 7265, 7266, 7267, 7269, 7270, 7272, 7273, 7274, 7275, 7276, 7277, 7278, 7279, 7280, 7281, 7282, 7283, 7284, 7285, 7286, 7287, 7288, 7289, 7290, 7291, 7292, 7293, 7294, 7295, 7296, 7297, 7299, 7300, 7302, 7304, 7305, 7306, 7307, 7308, 7309, 7310, 7311, 7312, 7313, 7314, 7315, 7316, 7317, 7319, 7320, 7321, 7322, 7323, 7324, 7325, 7326, 7327, 7328, 7329, 7330, 7331, 7332, 7333, 7334, 7335, 7336, 7337, 7338, 7339, 7340, 7341, 7342, 7343, 7344, 7345, 7346, 7347, 7348, 7349, 7350, 7351, 7352, 7353, 7354, 7355, 7356, 7357, 7358, 7359, 7360, 7361, 7362, 7363, 7364, 7365, 7366, 7367, 7368, 7369, 7370, 7371, 7372, 7373, 7374, 7376, 7377, 7378, 7379, 7381, 7382, 7385, 7387, 7388, 7389, 7391, 7392, 7393, 7394, 7395, 7397, 7398, 7399, 7400, 7401, 7403, 7404, 7405, 7406, 7409, 7410, 7411, 7412, 7413, 7414, 7415, 7416, 7417, 7418, 7419, 7420, 7421, 7422, 7423, 7424, 7425, 7426, 7428, 7429, 7431, 7432, 7433, 7434, 7435, 7436, 7437, 7438, 7440, 7441, 7442, 7443, 7444, 7445, 7446, 7447, 7448, 7449, 7450, 7451, 7454, 7455, 7456, 7457, 7459, 7462, 7463, 7464, 7465, 7466, 7467, 7468, 7469, 7470, 7471, 7472, 7473, 7474, 7475, 7476, 7477, 7478, 7479, 7480, 7481, 7482, 7483, 7484, 7485, 7487, 7488, 7489, 7490, 7491, 7492, 7493, 7494, 7495, 7496, 7497, 7498, 7499, 7500, 7501, 7502, 7503, 7504, 7505, 7506, 7507, 7508, 7509, 7511, 7512, 7513, 7515, 7516, 7517, 7518, 7519, 7521, 7522, 7523, 7524, 7526, 7527, 7528, 7530, 7531, 7532, 7534, 7535, 7537, 7539, 7540, 7542, 7544, 7545, 7547, 7548, 7549, 7550, 7551, 7552, 7553, 7554, 7555, 7556, 7558, 7559, 7560, 7561, 7562, 7564, 7565, 7566, 7568, 7569, 7573, 7574, 7577, 7578, 7579, 7580, 7581, 7582, 7584, 7585, 7588, 7589, 7590, 7591, 7592, 7593, 7596, 7597, 7598, 7599, 7601, 7602, 7603, 7605, 7608, 7609, 7611, 7612, 7613, 7615, 7616, 7617, 7618, 7620, 7622, 7623, 7624, 7626, 7627, 7628, 7629, 7630, 7634, 7635, 7637, 7638, 7639, 7640, 7641, 7642, 7643, 7644, 7645, 7646, 7647, 7648, 7649, 7650, 7652, 7655, 7656, 7657, 7658, 7659, 7661, 7662, 7663, 7665, 7666, 7667, 7671, 7672, 7673, 7674, 7675, 7677, 7678, 7679, 7680, 7681, 7682, 7684, 7685, 7686, 7687, 7689, 7690, 7691, 7693, 7695, 7696, 7698, 7699, 7700, 7701, 7702, 7703, 7704, 7705, 7706, 7707, 7709, 7715, 7716, 7718, 7720, 7724, 7725, 7727, 7729, 7730, 7731, 7735, 7736, 7737, 7739, 7740, 7741, 7743, 7744, 7745, 7749, 7750, 7751, 7752, 7753, 7754, 7755, 7757, 7758, 7759, 7761, 7762, 7763, 7765, 7768, 7769, 7770, 7774, 7775, 7776, 7777, 7779, 7782, 7783, 7784, 7785, 7786, 7787, 7788, 7791, 7793, 7794, 7795, 7796, 7797, 7799, 7800, 7801, 7802, 7803, 7806, 7807, 7808, 7810, 7811, 7812, 7814, 7815, 7818, 7820, 7823, 7824, 7827, 7828, 7833, 7834, 75000, 7536, 7541, 7688, 7595, 7572, 7636, 7268, 7614, 7190, 7529, 7600, 7402, 7710, 7571, 7654, 7252, 7632, 7453, 7244, 7486, 7533, 7557, 7538, 7607, 7708, 7052, 7660, 7407, 7384, 7576, 7318, 7427, 7390, 7546, 7668, 7651, 7587, 7697, 7200, 7172, 7121, 7375, 7396, 7408, 7586, 7452, 7514, 7683, 7631, 7510, 7380, 7543, 7430, 7621, 7301, 7528, 7383, 7155, 7520, 7439, 7610, 7619, 7180, 7386, 7525, 7570, 7271, 7694, 7653, 7575, 7458, 7676, 7583, 7182, 7176, 7669, and 7604.
- Product
- Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 765 units
- Distribution
- Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..
- Recall date
- March 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)