Device product
SmartPath to dStream for 1.5T, Magnetic Resonance System.
Z-1589-2024
Product summary
- Event
- Event 94233
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 672 units
- Official record key
device-enforcement:Z-1589-2024
Official wording
Reason: Patient support table floor plate may be incorrectly installed.
Code information: Model No. 781260, 782112; UDI-DI 884838095076, 884838098886; Serial No. 8954, 18726, 32174, 21664, 8906, 8578, 10703, 8835, 10154, 8971, 20226, 9001, 21665, 20204, 21108, 5475, 12033, 39024, 10196, 32131, 8630, 12034, 8772, 8091, 21555, 21294, 18561, 18761, 10482, 18800, 22285, 8560, 21788, 11064, 30146, 8100, 10036, 13052, 21023, 21290, 32094, 21223, 10717, 32142, 12134, 5572, 8378, 21003, 39103, 8566, 8190, 5523, 10511, 21611, 21612, 21888, 32184, 12084, 39003, 10079, 20198, 13032, 20071, 8642, 8318, 72054, 10170, 8178, 10174, 9022, 8087, 8923, 21438, 8591, 21033, 13018, 11030, 8119, 18665, 8427, 10061, 8895, 8706, 21253, 5511, 8601, 18808, 18655, 22060, 8608, 8352, 8481, 5490, 5479, 8819, 39005, 8118, 11031, 8857, 10915, 11042, 10544, 8948, 21019, 32450, 18663, 8646, 8884, 22098, 32506, 22127, 13062, 21175, 10075, 18801, 10164, 10498, 21880, 18690, 22299, 20111, 21050, 5466, 8084, 13047, 10029, 21142, 8611, 8395, 8311, 8786, 8215, 9013, 8554, 12115, 8783, 8260, 8478, 13011, 8639, 9004, 10139, 5546, 8387, 8896, 22154, 21278, 10191, 21129, 32221, 32218, 32449, 32443, 32445, 32444, 11085, 18644, 21067, 72243, 9007, 8712, 8942, 10183, 8667, 12030, 5463, 21912, 12114, 18038, 5537, 13029, 8025, 18101, 10457, 8750, 8752, 10044, 11091, 21498, 12072, 11062, 32311, 21554, 8057, 8779, 8746, 12055, 13069, 8559, 18565, 8309, 21156, 32147, 32410, 11046, 10554, 18511, 10220, 20057, 21481, 21679, 11102, 18631, 8200, 32849, 32513, 9006, 18610, 10906, 10130, 8086, 21560, 32264, 8804, 8021, 5447, 21697, 10513, 20033, 20302, 8831, 18970, 21676, 8840, 32180, 21084, 11076, 32374, 32742, 8330, 21015, 32621, 18512, 20112, 8392, 21458, 21184, 32361, 32140, 33126, 32492, 13046, 21759, 8365, 10900, 39037, 8641, 8060, 13001, 10185, 32405, 32643, 21466, 32200, 30037, 10719, 10086, 22107, 11000, 32176, 8407, 22342, 32752, 8240, 10913, 10570, 21062, 21942, 33100, 11001, 18509, 18035, 18697, 8531, 8512, 8985, 10523, 20319, 10151, 18060, 8010, 18558, 20151, 20152, 32710, 5505, 18597, 8354, 10033, 10716, 18673, 18701, 22189, 8704, 32636, 8129, 18069, 5539, 12036, 11072, 32438, 21691, 21171, 39031, 8251, 32092, 8263, 8397, 21680, 8156, 18929, 21392, 10179, 20002, 33051, 12047, 21623, 21969, 32391, 20322, 22102, 11108, 8843, 21929, 20116, 13082, 32127, 32113, 20237, 32341, 5499, 22055, 32990, 30067, 20011, 18107, 8760, 20278, 8983, 32754, 8305, 20003, 21349, 20195, 22296, 21355, 8723, 21384, 21591, 22103, 32822, 21748, 32334, 20211, 32245, 8913, 8713, 21222, 21011, 8168, 18746, 8292, 18704, 8110, 11005, 20164, 22013, 21987, 21551, 11017, 22301, 8094, 21583, 8561, 20209, 8451, 10543, 21780, 22100, 22137, 32296, 18938, 21694, 18957, 32049, 20187, 22220, 8711, 21640, 21182, 21403, 21213, 21804, 18720, 8887, 21209, 12120, 21579, 22070, 10552, 21519, 10007, 18524, 32454, 21736, 9020, 8550, 21448, 11018, 22227, 21141, 21477, 72081, 18699, 12082, 20196, 18954, 21249, 11100, 30097, 8736, 20115, 8885, 33220, 9024, 21018, 21892, 22194, 8074, 21362, 21768, 21814, 32680, 32807, 21621, 32283, 8492, 8862, 21775, 32099, 32163, 10117, 5484, 22184, 18853, 8315, 18017, 8657, 8476, 8401, 32573, 18906, 22144, 21453, 33352, 33023, 8694, 18985, 32145, 18986, 10530, 20413, 8045, 18583, 33062, 22237, 18013, 22248, 8975, 32467, 32059, 72239, 32217, 18948, 22157, 8517, 21082, 32258, 8486, 5536, 21710, 39009, 21247, 22044, 18575, 22347, 22175, 8321, 21133, 32164, 18718, 20035, 10008, 21089, 22123, 8175, 10528, 18894, 21890, 21577, 21326, 5425, 39018, 32340, 32119, 32322, 10102, 13023, 21127, 21809, 32236, 32845, 32478, 8096, 30132, 21979, 8213, 32132, 33385, 32778, 32285, 22031, 18559, 32286, 10161, 8456, 32839, 12121, 22266, 32923, 20165, 32134, 32262, 10461, 13026, 21359, 18965, 18851, 32953, 8166, 21792, 33106, 22255, 22257, 22256, 21333, 20182, 33215, 33366, 32359, 12009, 21138, 33044, 22152, 9032, 18548, 5550, 32670, 18574, 8424, 30239, 18788, 18988, 32333, 21746, 32316, 18670, 21671, 20160, 30033, 30139, 21994, 32458, 72250, 21995, 33246, 18803, 33716, 12053, 8798, 10169, 8109, 21212, 32798, 32803, 32804, 8573, 21298, 33179, 72275, 21684, 32719, 18998, 75012, 33019, 22298, 21090, 21433, 18950, 21685, 10040, 30031, 8734, 21379, 32580, 32577, 32041, 32661, 20099, 22290, 8808, 12029, 10028, 21893, 30089, 32457, 33565, 12002, 8766, 32158, 32827, 33546, 32426, 10190, 18857, 18776, 32725, 21608, 33082, 32709, 32696, 22027, 22267, 32355, 8298, 32539, 21513, 22048, 10521, 10128, 21164, 13021, 21940, 39106, 18520, 39070, 32844, 32378, 18892, 33639, 21158, 32412, 20159, 30054, 21740, 21726, 18942, 33371, 33103, 32133, 8876, 32724, 22247, 32419, 32349, 10222, 32363, 33404, 33217, 33033, 32327, 32364.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.
Derived failure modes
-
Unknown
Patient support table floor plate may be incorrectly installed.