Siemens Medical Solutions USA, Inc.: 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.

Recall number

Z-0208-2016

Recalling firm

Siemens Medical Solutions USA, Inc.

Product

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.

Status

Terminated

Initiated

2015-06-26

Posted

2015-11-04

Terminated

2016-12-23

Reason

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

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: In order for an injury to occur, the following series of events must be present; 1. The detector configuration angle must be 180 degrees. 2. The detector with the failed brake circuit must be above the patient. 3. The detector with the faulty brake circuit must be under power (in motion). 4. System power must cycle within a very short time period, preventing the brake circuit from charging. The 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. If you have any questions regarding this important safety notice, please contact your local Service representative at the contact numbers provided below. " America: 1-800-888-7436 " Europe, Middle East, and Africa: +49 9131 940 4000 " Asia and Australia: +86 (21) 3811 2121 Local Service representative at the contact numbers provided below. " America: 1-800-888-7436 " Europe, Middle East, and Africa: +49 9131 940 4000 " Asia and Australia: +86 (21) 3811 2121

Quantity

32296 e.cam Gamma Camera systems

Distribution

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.

Lot, serial or model codes

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, 126110, 21909, 26011, 31609, 31711, 31827, 41207, 62111, 62310, 7030, 71410, 71411, 7440, 7502, 7582, 8149, 82409, 9, 918073, 1002, 1006, 1009, 1013, 1014, 1015, 1016, 1019, 1020, 1021, 1024, 1029, 1034, 1036, 1037, 1038, 1039, 1046, 1049, 1052, 1056, 1058, 1059, 1062, 1063, 1065, 1067, 1071, 1077, 1080, 1081, 1082, 1083, 1088, 1089, 1094, 1095, 1099, 1101, 1103, 1104, 1105, 1107, 1109, 1110, 1113, 1114, 1116, 1118, 1121, 1129, 1130, 1131, 1135, 1136, 1137, 1138, 1139, 1141, 1142, 1143, 2001, 2004, 2006, 2007, 2008, 2010, 2012, 2013, 2014, 2015, 2017, 2019, 2024, 2026, 2027, 2028, 2030, 2036, 2038, 2039, 2041, 2042, 2045, 2047, 2048, 2050, 2051, 2052, 2055, 2058, 2060, 2065, 2066, 2074, 2075, 2076, 2078, 2079, 2080, 2081, 2084, 2090, 2096, 2098, 2099, 2100, 2107, 2114, 2115, 2117, 2118, 2119, 2120, 2122, 2123, 2124, 2125, 2127, 2128, 2130, 3004, 3005, 3007, 3008, 3010, 3015, 3016, 3018, 3020, 3022, 3023, 3026, 3027, 3029, 3032, 3035, 3037, 3039, 3040, 3045, 3047, 3048, 3049, 3050, 3051, 3052, 3055, 3056, 3057, 3058, 3064, 3065, 3067, 3069, 3070, 3071, 3075, 3076, 3077, 3080, 3082, 3083, 3085, 3087, 3088, 3090, 3091, 3092, 3093, 3094, 3096, 3098, 3100, 3101, 3104, 3105, 3106, 3107, 3109, 3112, 3114, 3115, 3116, 3117, 3118, 3120, 3121, 3122, 3123, 3124, 3125, 3132, 3133, 3135, 3137, 3138, 3139, 3140, 3141, 4001, 4002, 4004, 4006, 4007, 4008, 4010, 4011, 4012, 4014, 4015, 4017, 4018, 4019, 4021, 4022, 4023, 4024, 4025, 4026, 4028, 4030, 4034, 4039, 4041, 4044, 4045, 4048, 4049, 4050, 4052, 4053, 4054, 4056, 4057, 4060, 4062, 4063, 4064, 4066, 4067, 4068, 4069, 4070, 4071, 4076, 4077, 4078, 4090, 10209, 10411, 12210, 12310, 31611, 40109, 4082, 4083, 4084, 4086, 4095, 4096, 4097, 4098, 4100, 4107, 4112, 4114, 4116, 4117, 4118, 4119, 4120, 4121, 4122, 4125, 4127, 4129, 4130, 4131, 4132, 4135, 4136, 4137, 4141, 4142, 4143, 4146, 4147, 4148, 4149, 4151, 4152, 4154, 4156, 4158, 4159, 4164, 4166, 4168, 4171, 4173, 4174, 4177, 4178, 4179, 4181, 4182, 4183, 4185, 4186, 4190, 4196, 4197, 4202, 4205, 4206, 4208, 4209, 4214, 4215, 4217, 4218, 4219, 4220, 4221, 4222, 4223, 4225, 4226, 5001, 5002, 5004, 5005, 5006, 5008, 5009, 5011, 5012, 5013, 5016, 5017, 5018, 5019, 5020, 5021, 5022, 5023, 5024, 5025, 5027, 5029, 5031, 5032, 5033, 5036, 5037, 5039, 5040, 5041, 5042, 5043, 5045, 5046, 5048, 5049, 5050, 5051, 5057, 5060, 5063, 5067, 5069, 5070, 5071, 5102, 5107, 5108, 5117, 5123, 6000, 60911, 62211, 83110, 83210, 92110, 4017, 4018, 4019, 4022, 4023, 4025, 4030, 4032, 4033, 4034, 4035, 4037, 4044, 4046, 4049, 5001, 5003, 5004, 5006, 5007, 5008, 5010, 5011, 5012, 5013, 5015, 5016, 5017, 5018, 5020, 5021, 5022, 5024, 5025, 5028, 5031, 5033, 5036, 5037, 5039, 5040, 5043, 3, 6006, 6007, 6009, 6010, 7001, 7004, 7006, 7409, 7501, 7502, 7507, 7509, 6053, 6501, 7386, 7502, 7504, 7505, 7507, 7508, 7510, 7512, 7513, 7515, 7516, 7517, 7518, 7519, 7520, 7521, 7522, 7523, 7525, 7526, 7529, 7531, 7533, 7534, 7535, 7536, 7538, 7539, 7540, 7542, 7545, 7547, 7548, 7549, 7550, 7551, 7553, 7555, 7556, 7557, 7558, 7561, 7562, 7563, 7564, 7566, 7568, 7569, 7573, 7574, 7576, 7577, 7578, 7579, 7581, 7582, 7584, 7587, 7588, 7589, 7590, 7592, 7595, 7596, 7599, 7600, 7602, 7605, 7606, 7608, 7610, 7611, 7614, 7615, 7616, 7617, 7618, 7618*, 7620, 7621, 7622, 7623, 7624, 7626, 7627, 7628, 7629, 7631, 7635, 7636, 7637, 7638, 7651, 7861, 8001, 8003, 8005, 8006, 8007, 8009, 8010, 8011, 8014, 8015, 8017, 8020, 8021, 8023, 8024, 8025, 8027, 8028, 8029, 8030, 8031, 8032, 8035, 8036, 8037, 8039, 8040, 8044, 8045, 8047, 8049, 8050, 8051, 8053, 8055, 8056, 8057, 8058, 8059, 8060, 8063, 8064, 8067, 8069, 8070, 8071, 8072, 8073, 8075, 8078, 8079, 8080, 8081, 8082, 8085, 8087, 8088, 8089, 8090, 8092, 8094, 8095, 8096, 8097, 8098, 8099, 8100, 8102, 8105, 8106, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, 8119, 8120, 8121, 8122, 8124, 8125, 8126, 8127, 8128, 8130, 8131, 8132, 8133, 8135, 8137, 8138, 8141, 8142, 8144, 8145, 8146, 8147, 8501, 8502, 8503, 8504, 8505, 8506, 8508, 8510, 8511, 8512, 8513, 8514, 8515, 8516, 8517, 8518, 8519, 8520, 8521, 8522, 8523, 8524, 8525, 8526, 8527, 8528, 8529, 8530, 8532, 8533, 8534, 8535, 8536, 8538, 8540, 8541, 8543, 8544, 8545, 8548, 8549, 8550, 8552, 8553, 8556, 8558, 8559, 8560, 8561, 8562, 8563, 8564, 8565, 8567, 8568, 8569, 8570, 8571, 8572, 8573, 8574, 8575, 8576, 8577, 8578, 8580, 8581, 8583, 8585, 8586, 8587, 8588, 8589, 8590, 8592, 8593, 8595, 8596, 8598, 8600, 8603, 8604, 8605, 8606, 8607, 8608, 8609, 8610, 8611, 8612, 8613, 8615, 8616, 8617, 8618, 8619, 8620, 8621, 8622, 8624, 8625, 8626, 8628, 8629, 8630, 8631, 8632, 8633, 8634, 8635, 8636, 8637, 8638, 8639, 8640, 8641, 8642, 8643, 8645, 8646, 8647, 8650, 8651, 8652, 8653, 8654, 8655, 8656, 8657, 8658, 8659, 8660, 8661, 8662, 8665, 8666, 8667, 8668, 8669, 8670, 8671, 8672, 8673, 8674, 8675, 8676, 8677, 8678, 8679, 8681, 8683, 8684, 8685, 8686, 8687, 8688, 8689, 8690, 8691, 8692, 8693, 8694, 8695, 8696, 8697, 8698, 8699, 8700, 8701, 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, 9023, 9024, 9026, 9027, 9028, 9029, 9030, 9031, 9032, 9033, 9034, 9035, 9036, 9037, 9038, 9039, 9041, 9043, 8473046345, 8503, 8205, 8505, 8506, 8509, 8510, 8511, 8513, 8514, 8515, 8516, 8517, 8518, 8519, 8520, 9821, 8501, 8501*, 8502, 8507, 8508, 10000, 10001, 10002, 10003, 10005, 10006, 10007, 10008, 10009, 10010, 10013, 10014, 10015, 10016, 10017, 10019, 10020, 10022, 10023, 10024, 10025, 10026, 10028, 10029, 10030, 10031, 10032, 10033, 10034, 10035, 10036, 10037, 10038, 10040, 10041, 10042, 10044, 10046, 10047, 10048, 10049, 10050, 10051, 10052, 10053, 10054, 10055, 10056, 10057, 10058, 10059, 10060, 10061, 10062, 10063, 10065, 10066, 10067, 10068, 10069, 10070, 10071, 10072, 10073, 10074, 10076, 10077, 10078, 10079, 10080, 10082, 10083, 10084, 10085, 10087, 10088, 10089, 10090, 10091, 10092, 10093, 10094, 10096, 10098, 10099, 10100, 10101, 10102, 10103, 10104, 10106, 10107, 10108, 10109, 10111, 10112, 10113, 10114, 10115, 10117, 10118, 10119, 10120, 10121, 10122, 10124, 10125, 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.

510(k) numbers

["K142006"]

PMA numbers

not on file

Product code

KPS

Firm FEI

1000514697

Firm city

Hoffman Estates

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy