FDAFDA · Alimentos y medicamentos·N.º oficial Z-0707-2024
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) XSCRIBE CP SW KIT, 41000-030-64
Publicado el 17 de enero de 2024 · Inicio del retiro: 8 de diciembre de 2023
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Baxter Healthcare Corporation
- Distribuidor
- United States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei, Chia, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Thailand, Algeria, Angola, Austria, Bahrain, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Argentina, Bahamas, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, and Trinidad and Tobago.
- Lote
- Product Code, UDI/DI Number, Serial Numbers a) 41000-030-50, UDI/DI None, Serial Numbers: 110120039437, 110120039438, 110120039439, 110190044556, 110190044557, 110190044558, 110190044559, 110190044560, 110190044561, 110190044562, 110190044563, 110190044564, 110190044565, 110190044566, 110190044567, 110200045831, 110200045832, 110200045833, 110200045834, 110200045835, 110260052818, 110260052819, 110260052820, 110260052821, 110260052822, 110260052823, 110420061166, 110420061167, 110420061168, 110420061169, 110460064753, 110460064754, 110460064755, 110460064697, 110460064698, 110460064699, 110460064700, 110460064702, 110460064703, 110460064704, 110460064705, 110460064706, 111150077803, 111150077804, 111150077805, 111150077806, 111150077807, 111150077808, 111150077809, 111200081334, 111200081335, 111200081336, 111200081337, 111200081338, 111200081339, 111200081340, 111200081341, 111300088621, 111300088622, 111300088623, 111300088624, 111300088625, 111300088626, 111300088627, 111340091242, 111340091243, 111360092140, 111360092141, 111360092142, 111360092143, 111360092144, 111340091246, 111340091247, 111340091248, 111340091249, 111340091250, 111420097839, 111420097840, 111420097841, 111420097842, 111420097843, 111500103083, 111500103084, 111500103085, 111500103086, 111530104948, 111530104949, 111530104950, 111530104951, 112020106363, 112020106364, 112020106365, 112020106366, 112020106367, 112020106368, 112020106369, 112020106370, 112180115629, 112180115630, 112180115631, 112180115632, 112180115633, 112180115634, 112180115635, 112200117094, 112200117095, 112200117096, 112200117097, 112200117098, 112200117099, 112200117100, 112200117101, 112200117102, 112200117103, 112320128027, 112320128028, 112320128029, 112320128030, 112320128031, 112350130930, 112350130931, 112350130932, 112350130933, 112350130934, 112350130935, 112350130936, 112350130937, 112440138921, 112440138922, 112440138923, 112440138924, 112440138925, 112440138926, 112440138927, 112440138928, 112440138929, 112440138930, 112440138931, 112440138932, 113010147090, 113010147091, 113010147092, 113010147093, 113070153116, 113070153117, 113070153118, 113070153119, 113070153120, 113070153121, 113070153122, 113070153123, 113070153124, 113070153125, 113070153126, 113070153127, 113070153128, 113070153129, 113270168996, 113270168997, 113270168998, 113270168999, 113270169000, 113310172113, 113310172114, 113310172115, 113310172116, 113350174038, 113350174039, 113350174040, 113350174041, 113350174046, 113350174047, 113350174042, 113350174043, 113350174044, 113350174045, 113410177775, 113410177776, 113410177777, 113410177778, 113410177779, 113410177780, 113410177781, 113440180951, 113440180952, 113440180953, 113470184299, 113470184300, 113470184301, 113530189429, 113530189430, 113530189431, 113530189432, 113530189433, 113530189434, 114050192901, 114050192902, 114050192903, 114090196065, 114090196066, 114090196067, 113460182788, 113460182789, 113460182790, 113460182791, 113460182792, 113460182793, 114420232656, 114420232657, 114420232658, 114420232659, 114420232660, 114420232661, 114480237409, 114480237410, 114420232662, 114420232663, 114420232664, 114420232665, 114520240984, 114520240985, 114520240986, 114520240987, 114520240988, 114520240989, 115050243901, 115050243902, 115050243903, 114470236646, 114470236647, 114470236648, 115230258572, 115230258573, 115230258574, 115230258575, 115230258576, 115230258424, 115230258425, 115230258426, 115280263454, 115280263455, 115280263456, 115280263457, 115280263458, 115280263459, 115280264206, 115280264207, 115280264208, 115280264209, 115280264210, 115280264211, 115330268899, 115330268900, 115330268901, 115330268902, 115330268903, 115330268904, 115400275479, 115400275480, 115400275481, 115400275482, 115400275483, 115400275484, 115400275485, 115400275486, 115400275487, 115400275488, 116020287198, 116020287199, 116020287200, 116100335156, 116100335157, 116100335158, 116130382423, 116130382424, 116130382425, 116130382426, 116130382427, 116180422043, 11
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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