{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "140495", "product_res_number": "Z-0208-2016", "event_date_initiated": "2015-06-26", "event_date_posted": "2015-11-04", "recall_status": "Terminated", "event_date_terminated": "2016-12-23", "res_event_number": "72296", "product_code": "KPS", "k_numbers": [ "K142006" ], "product_description": "e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.", "code_info": "E.cam Model numbers affected : 4380213, 4380221, 5242826, 5077066, 5077074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7324119, 7324135, 7324143, 7324150, 7760809, 7760932, 7760161, 7761161, 7823920, 7823938, 7823946, 7823953, 7823961, 7823979, 10151531, 10151532, 10520745. This recall applies only to ecam systems that were installed before December 31st 2004.  Serial Numbers 7438, 7440, 81010, 1011, 8509, 8510, 1, 1007, 1008, 1010, 1019, 1020, 2001, 2004, 2006, 2007, 2009, 2010, 2014, 2017, 2019, 2022, 2023, 2025, 3002, 3006, 3008, 3010, 3011, 3012, 3013, 3014, 3017, 3021, 3022, 3023, 3024, 3029, 3031, 3034, 4001, 4002, 4004, 4008, 4009, 4010, 4011, 4013, 4014, 4016, 1006, 1009, 1015, 1016, 1020, 1021, 1024, 1025, 1029, 1030, 1031, 1032, 1033, 1041, 1044, 1046, 1051, 1056, 1057, 1063, 1068, 1069, 1070, 1071, 10711, 1074, 1076, 1077, 1079, 1084, 1092, 1095, 1096, 1098, 1100, 1102, 1105, 1106, 1111, 1116, 1117, 1118, 1122, 1123, 1124, 1127, 1130, 1132, 1133, 1134, 1135, 1136, 1137, 1142, 1143, 1146, 1148, 1150, 1151, 1153, 1155, 1157, 1158, 1160, 1161, 1162, 1163, 1165, 1166, 1169, 1172, 1174, 1176, 1180, 1181, 1182, 1184, 1186, 1187, 1188, 1189, 1190, 1191, 1192, 1196, 1197, 1199, 1200, 12009, 1201, 1202, 1205, 1206, 1207, 1208, 121010, 1211, 1234, 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8702, 8703, 8704, 8705, 8706, 8707, 8708, 8709, 8710, 8711, 8712, 8714, 8716, 8717, 8718, 8719, 8720, 8721, 8722, 8723, 8724, 8725, 8726, 8727, 8728, 8729, 8730, 8731, 8732, 8733, 8734, 8735, 8736, 8738, 8739, 8740, 8741, 8743, 8744, 8745, 8746, 8747, 8748, 8749, 8750, 8754, 8755, 8756, 8757, 8758, 8759, 8760, 8761, 8763, 8766, 8767, 8769, 8770, 8771, 8773, 8778, 8779, 8780, 8781, 8782, 8783, 8784, 8786, 8788, 8789, 8790, 8791, 8792, 8793, 8794, 8799, 8801, 8802, 8803, 8804, 8805, 8807, 8808, 8809, 8810, 8811, 8812, 8813, 8814, 8816, 8817, 8818, 8819, 8820, 8822, 8823, 8824, 8825, 8827, 8828, 8829, 8830, 8831, 8832, 8833, 8834, 8835, 8836, 8837, 8838, 8839, 8841, 8842, 8844, 5045, 7502, 7503, 7505, 7506, 7509, 7511, 8001, 8003, 8004, 8007, 8009, 8010, 8012, 8013, 8014, 8015, 8016, 8017, 8019, 8021, 8022, 8024, 8025, 8027, 8028, 8030, 8032, 8501, 8503, 8504, 8506, 8507, 8508, 8509, 8511, 8512, 8513, 8514, 8517, 8518, 8519, 8521, 8523, 8524, 8525, 8526, 8528, 8530, 8532, 8534, 8535, 8536, 8537, 8539, 8540, 8543, 8545, 8547, 8548, 8549, 8550, 8552, 8553, 8554, 8555, 8556, 7090, 7502, 7504, 7505, 8001, 8003, 8005, 8021, 8501, 8502, 8503, 8504, 8505, 8506, 1001, 13044, 5039, 5505, 5507, 5508, 5510, 5511, 5512, 5514, 5517, 5518, 5519, 5521, 5522, 5523, 5524, 5525, 5526, 5527, 5528, 5529, 5530, 5531, 5532, 5533, 5535, 5536, 5537, 5538, 5539, 5540, 5541, 5542, 5546, 5547, 5548, 5550, 5551, 5553, 5555, 5556, 5557, 5558, 5559, 5560, 5561, 5562, 5563, 5565, 5567, 5570, 5571, 5572, 5573, 5575, 5578, 5579, 5580, 5581, 5584, 5585, 5586, 5587, 5588, 5589, 5590, 5591, 5593, 5594, 5595, 5597, 5599, 5600, 5601, 5602, 5603, 5604, 5605, 5606, 5607, 5608, 5609, 5610, 5611, 5612, 5613, 5614, 5616, 5617, 5618, 5620, 5622, 5623, 5624, 5625, 5629, 5631, 5632, 5634, 5636, 5637, 5639, 5640, 5642, 5644, 5645, 5646, 5647, 5649, 5650, 5658, 5671, 5672, 5673, 5674, 5675, 5676, 5677, 5678, 5679, 7005, 7006, 7007, 7009, 7011, 7012, 7013, 7014, 7016, 7017, 7018, 7019, 7020, 7022, 7025, 7027, 7028, 7029, 7030, 7031, 7032, 7033, 7034, 7036, 7037, 7039, 7040, 7041, 7043, 7044, 7045, 7046, 7047, 7048, 7049, 7050, 7051, 7056, 7058, 7059, 7060, 7061, 7062, 7063, 7065, 7067, 7068, 7069, 7070, 7073, 7076, 7078, 7080, 7082, 7083, 7084, 7086, 7088, 7090, 7091, 7092, 7094, 7095, 7096, 7097, 7098, 7102, 7103, 7104, 7105, 7109, 7110, 7111, 7112, 7117, 7120, 7121, 7124, 7126, 7127, 7501, 7502, 7503, 7504, 7505, 7506, 7508, 7509, 7510, 7512, 7513, 7515, 7516, 7517, 7519, 7520, 7521, 7523, 7524, 7525, 7526, 7530, 7531, 7532, 7533, 7534, 7535, 7536, 7537, 7538, 7539, 7541, 7544, 7545, 7551, 7552, 7553, 7555, 7556, 7557, 7560, 7561, 7562, CAX271/U2B004, 5501, 5502, 5503, 5506, 5511, 5512, 5513, 5514, 5516, 5517, 5519, 5521, 5523, 5525, 5526, 5527, 5529, 7003, 7004, 7005, 7006, 7008, 7011, 7013, 7015, 7017, 7018, 7019, 7020, 7021, 7022, 7024, 7025, 7026, 7501, 7504, 7506, 7507, 7508, 7509, 7513, 5101, 5102, 5104, 5109, 5110, 5112, 5113, 5115, 5116, 5118, 5121, 5125, 5126, 5127, 5128, 5131, 5132, 5133, 5135, 5136, 5142, 5144, 5146, 5147, 5148, 5149, 5150, 5151, 5153, 5157, 5158, 5159, 5160, 5162, 5165, 5167, 5168, 5170, 5171, 5172, 5173, 5174, 5502, 1003, 548, 550, 558, 564, 579, 581, 588, 589, 590, 592, 593, 595, RC528, RC537, RC549, 551, 584, RC521, RC536, 10610, 21511, 510, 529, 530, 557, 559, 573, 62310, RC498, RC543, 556, 572, RC493, RC524, RC538, RC541, RC545, RC546, 8501, 8503, 8504, 8505, 8506, 8508, 8509, 8510, 8511, 100003, 1234, 1234578, 4916, 60151, 63010, 7409, 7502, 8191, 8501, 8502, 8503, 8506, 8507, 8508, 8509, 8512, 8514, 8515, 8517, 8519, 8520, 8521, 8522, 8523, 8524, 8525, 8529, 8530, 8531, 8532, 8533, 8534, 8537, 8538, 8539, 8540, 8541, 8542, 8543, 8544, 8546, 8547, 8548, 8549, 8550, 8551, 8552, 8553, 8554, 8555, 8556, 8557, 8560, 8561, 8562, 8563, 8564, 8565, 8566, 8567, 8568, 8569, 8570, 8571, 8572, 8573, 8574, 8577, 8578, 8579, 8580, 8581, 8583, 9003, 9004, 9006, 9007, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9022, 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10126, 10127, 10128, 10129, 10130, 10131, 10132, 10133, 10135, 10136, 10137, 10138, 10139, 10140, 10141, 10142, 10143, 10144, 10147, 10149, 10150, 10151, 10153, 10154, 10155, 10156, 10157, 10158, 10159, 10160, 10161, 10162, 10163, 10164, 10165, 10166, 10167, 10168, 10169, 10170, 10171, 10172, 10173, 10174, 10175, 10176, 10177, 10178, 10179, 10180, 10181, 10182, 10183, 10184, 10185, 10186, 10187, 10188, 10191, 10192, 10193, 10194, 10195, 10198, 10199, 10200, 10201, 10202, 10203, 10204, 10205, 10206, 10207, 10208, 10209, 10211, 10212, 10213, 10214, 10215, 10216, 10217, 10218, 10219, 10220, 10221, 10222, 10224, 10225, 10226, 10227, 10228, 10230, 10231, 10232, 10233, 10234, 10235, 10236, 10237.10238, 10239, 10240, 10241, 10243, 10245, 10246, 10248, 10249, 10250, 10251, 10252, 10253, 10254, 10255, 10256, 10257, 10258, 10259, 10260, 10261, 10262, 10263, 10264, 10265, 10266, 10267, 10268, 10269, 10270, 10271, 10272, 10273, 10274, 10275, 10276, 10277, 10278, 10280, 10282, 10283, 10284, 10285, 10286, 10287, 10288, 10289, 10290, 10291, 10292, 10293, 10294, 10295, 10296, 10297, 10298, 10299, 10300, 10301, 10302, 10303, 10304, 10305, 10306, 10307, 10308, 10309, 10310, 10311, 10312, 10313, 10314, 10315, 10317, 10318, 10319, 10320, 10321, 10322, 10323, 10324, 10325, 10326, 10327, 10328, 10329, 10330, 10331, 10332, 10333, 10334, 10336, 10337, 10338, 10339, 10340, 10341, 10343, 10344, 5382, 5517, 5764, 8490, 9001, 9002, 9003, 9004, 9005, 9006, 9008, 9009, 9010, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9022, 9023, 9024, 9025, 9026, 9027, 9028, 9031, 9033, 9034, 9035, 9036, 9038, 9039, 9040, 9041, 9043, 9044, 9045, 9046, 9047, 9049, 9050, 9051, 9053, 9054, 9055, 9057, 9058, 9059, 9060, 9061, 9062, 9063, 9064, 9066, 9068, 9069, 9070, 9073, 9074, 9076, 9077, 9078, 9079, 9080, 9081, 9082, 9083, 9084, 9085, 9086, 9087, 9089, 9090, 9091, 9092, 9094, 9095, 9096, 9097, 9098, 9099, 9100, 9101, 9102, 9103, 9104, 9106, 9107, 9108, 9109, 9110, 9111, 9112, 9113, 9114, 9115, 9116, 9117, 9120, 9122, 9123, 9124, 9125, 9126, 9127, 9129, 9130, 9132, 9133, 9134, 9135, 9136, 9137, 9138, 9139, 9142, 9143, 9144, 9145, 9146, 9147, 9148, 9149, 9150, 9151, 9152, 9154, 9155, 9156, 9157, 9158, 9159, 9161, 9162, 9163, 9164, 9165, 9166, 9167, 9169, 9170, 9171, 9172, 9173, 9174, 9175, 9176, 9177, 9179, 9180, 9181, 9182, 9183, 9184, 9185, 9186, 9187, 9189, 9190, 9191, 9193, 9194, 9198, 9199, 9200, 9201, 9204, 9206, 9207, 9210, 9212, 9213, 9214, 9215, 9216, 9219, 9220, 9221, 9223, 9224, 9225, 9226, 9227, 9228, 9230, 9231, 9232, 9233, 9234, 9235, 9238, 9239, 9240, 9241, 9242, 9243, 9245, 9246, 9247, 9248, 9251, 9252, 9253, 9254, 9255, 9256, 9259, 9260, 9261, 9262, 9263, 9264, 9265, 9266, 9267, 9268, 9269, 9270, 9271, 9272, 9273, 9274, 9275, 9276, 9277, 9279, 9280, 9281, 9282, 9283, 9284, 9285, 9287, 9288, 9289, 9290, 9292, 9293, 9294, 9295, 9296, 9297, 9298, 9299, 9300, 9301, 9302, 9303, 9304, 9305, 9306, 9307, 9308, 9309, 9311, 9313, 10001, 10002, 10003, 10004, 10005, 10006, 10007, 10008, 10009, 10011, 10012, 10014, 10015, 10016, 10017, 10018, 10019, 10022, 10023, 10025, 10026, 10027, 10028, 10029, 10030, 10031, 10032, 10034, 10035, 10036, 10038, 10039, 10040, 10041, 10044, 10045, 10046, 10047, 10048, 10049, 10050, 10051, 10052, 10055, 10056, 10057, 10058, 10059, 10061, 8505, 8509, 9001, 9002, 9003, 9004, 9005, 9007, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9019, 9020, 9021, 9022, 9024, 9026, 9031, 9032, 9033, 9034, 9036, 9037, 9038, 9039, 9040, 9041, 9042, 9043, 9044, 9045, 9001, 9002, 9005, 9006, 9007, 9009, 9010, 9011, 9013, 9014, 9016, and 9017.", "firm_fei_number": "1000514697", "recalling_firm": "Siemens Medical Solutions USA, Inc.", "address_1": "2501 Barrington Rd", "city": "Hoffman Estates", "state": "IL", "postal_code": "60192-2061", "additional_info_contact": "847-304-7700", "reason_for_recall": "Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized.", "root_cause_description": "Component design/selection", "action": "The firm, Siemens, sent out an undated \"CUSTOMER SAFETY ADVISORY NOTICE\" on 04 April 2015 to its consignees informing them of the e.com system safety update. The notice described the product, problem and actions to be taken. The notice stated the following:\n\nIn order for an injury to occur, the following series of events must be present;\n1. The detector configuration angle must be 180 degrees.\n2. The detector with the failed brake circuit must be above the patient.\n3. The detector with the faulty brake circuit must be under power (in motion).\n4. System power must cycle within a very short time period, preventing the brake circuit from charging.\n\nThe customers were instructed to continue to use their e.com system and to ensure the safety advisory is placed in the systems instructions for use and to observe patients while system is in use. If they experience difficulty or failure while performing the daily touch pad test, they are advised to discontinue use and contact their local representative. If unintended movement is detected they are advised to remove the patient and discontinue using the system and contact their local service representative. \n\nIf you have any questions regarding this important safety notice, please contact your local Service representative at the contact numbers provided below.\n\" America: 1-800-888-7436\n\" Europe, Middle East, and Africa: +49 9131 940 4000\n\" Asia and Australia: +86 (21) 3811 2121\n\n\n\n\n\n\n\nLocal Service representative at the contact numbers provided below.\n\"\tAmerica: 1-800-888-7436\n\"\tEurope, Middle East, and Africa: +49 9131 940 4000\n\"\tAsia and Australia: +86 (21) 3811 2121", "product_quantity": "32296 e.cam Gamma Camera systems", "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: United Arab Emirates, Albania, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, Cameroon, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominica, Ecuador, Egypt, Spain, Finland, France, United Kingdom, Georgia, Greece, Croatia, Canary Islands, Ireland, Israel, India, Iraq, Iran, Islamic-Republic of, Italy, Jordan, Japan, Korea-Republic of, Kuwait, Lebanon, Sri Lanka, Luxembourg, Latvia, Morocco, Myanmar, Mauritius, Mexico, Malaysia, Netherlands, Norway, Nepal, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Portugal, Qatar, Serbia, Russian Federation, Saudi Arabia, Sweden, Slovakia, El Salvador, Syrian Arab Republic (Syria), Thailand, Tunisia, Turkey, Taiwan, Republic of China, Ukraine, Uganda, Uzbekistan, and South Africa.", "openfda": { "k_number": [ "K013504", "K113448", "K031705", "K001276", "K073021", "K926133", "K240827", "K011572", "K131634", "K251370", "K963273", "K110507", "K261315", "K790169", "K130269", "K243186", "K781753", "K161740", "K000908", "K043293", "K050366", "K942146", "K231748", "K061587", "K994167", "K014033", "K140206", "K923736", "K081496", "K130451", 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"device_class": "2", "registration_number": [ "3026047529", "3032577207", "3012690638", "3029521953", "3027338963", "3012085143", "3002808157", "3014954414", "2134213", "3036666444", "3009963139", "1066019", "3011015597", "3005945241", "3016007746", "3008355361", "3031503890", "2320968", "8030233", "3004754211", "1423253", "2247992", "3014470527", "3011416394", "3008007310", "3008632256", "9613299", "3015276088", "9613936", "1450662", "3018788582", "3023003446", "3030982377", "3013679558", "3010703925", "3008962177", "3027339477", "3010398867", "3004504920", "3017375271", "3006209933", "3000126629", "3006611212", "3033524251", "9613445", "3005810333", "3015777306", "3014134519", "3008496839", "3009196578", "3009136051", "1424263", "2126677", "9710645", "1034973", "9614698", "3011950073", "2031050", "3015232217", "3007675950", "3012761544", "3005877899", "3022742930", "8022257", "1833124", "3015763655", "3021059265", "3035950510", "2411512", "9617978", "3005128583", "3014343100", 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