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Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728...

FDA Device Recall #Z-0880-2013 — Class II — October 24, 2012

Recall Summary

Recall Number Z-0880-2013
Classification Class II — Moderate risk
Date Initiated October 24, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Medical Systems (Cleveland) Inc
Location Cleveland, OH
Product Type Devices
Quantity 765 units

Product Description

Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.

Reason for Recall

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

Distribution Pattern

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..

Lot / Code Information

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.

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Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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