FDAFDA · Alimentos y medicamentos·N.º oficial Z-2172-2024

CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6) 2095802-001-54069330, 7) 2095802-001-554922, 8) 2095802-001-554923, 9) 2095802-001-554924, 10) 2095802-001-554925, 11) 2095802-001-554926, 12) 2095802-001-554927, 13) 2095802-001-554928, 14) 2095802-001-555120, 15) 2095802-001-556223, 16) 2095802-001-557346, 17) 2095802-001-558678, 18) 2095802-001-558707, 19) 2095802-001-559208, 20) 2095802-001-559337, 21) 2095802-001-559916, 22) 2095802-001-560446, 23) 2095802-001-560519, 24) 2095802-001-560520, 25) 2095802-001-560521, 26) 2095802-001-560522, 27) 2095802-001-560637, 28) 2095802-001-560803, 29) 2095802-001-561557, 30) 2095802-001-562090, 31) 2095802-001-562136, 32) 2095802-001-562249, 33) 2095802-001-562799, 34) 2095802-001-563317, 35) 2095802-001-563770, 36) 2095802-001-563771, 37) 2095802-001-564033, 38) 2095802-001-564174, 39) 2095802-001-565603, 40) 2095802-001-566307, 41) 2095802-001-566308, 42) 2095802-001-566696, 43) 2095802-001-566798, 44) 2095802-001-566816, 45) 2095802-001-566825, 46) 2095802-001-566826, 47) 2095802-001-566925, 48) 2095802-001-567844, 49) 2095802-001-568125, 50) 2095802-001-568726, 51) 2095802-001-568765, 52) 2095802-001-569226, 53) 2095802-001-569235, 54) 2095802-001-569318, 55) 2095802-001-569322, 56) 2095802-001-569329, 57) 2095802-001-569332, 58) 2095802-001-569426, 59) 2095802-001-569860, 60) 2095802-001-569871, 61) 2095802-001-569990, 62) 2095802-001-570062, 63) 2095802-001-570185, 64) 2095802-001-570746, 65) 2095802-001-570960, 66) 2095802-001-571048, 67) 2095802-001-571049, 68) 2095802-001-571801, 69) 2095802-001-571807, 70) 2095802-001-572988, 71) 2095802-001-572991, 72) 2095802-001-573205, 73) 2095802-001-574167, 74) 2095802-001-574403, 75) 2095802-001-574569, 76) 2095802-001-574570, 77) 2095802-001-574685, 78) 2095802-001-575604, 79) 2095802-001-575842, 80) 2095802-001-576569, 81) 2095802-001-577254, 82) 2095802-001-577260, 83) 2095802-001-577472, 84) 2095802-001-577688, 85) 2095802-001-578467, 86) 2095802-001-578468, 87) 2095802-001-579029, 88) 2095802-001-579134, 89) 2095802-001-579366, 90) 2095802-001-579526, 91) 2095802-001-579590, 92) 2095802-001-579604, 93) 2095802-001-579692, 94) 2095802-001-579926, 95) 2095802-001-579933, 96) 2095802-001-580487, 97) 2095802-001-580731, 98) 2095802-001-581010, 99) 2095802-001-581094, 100) 2095802-001-581417, 101) 2095802-001-581433, 102) 2095802-001-582510, 103) 2095802-001-582710, 104) 2095802-001-582906, 105) 2095802-001-582907, 106) 2095802-001-583150, 107) 2095802-001-583551, 108) 2095802-001-583553, 109) 2095802-001-583888, 110) 2095802-001-583970, 111) 2095802-001-584288, 112) 2095802-001-584547, 113) 2095802-001-584810, 114) 2095802-001-585047, 115) 2095802-001-585468, 116) 2095802-001-585907, 117) 2095802-001-586028, 118) 2095802-001-586829, 119) 2095802-001-587286, 120) 2095802-001-587726, 121) 2095802-001-587767, 122) 2095802-001-587770, 123) 2095802-001-588006, 124) 2095802-001-588111, 125) 2095802-001-588571, 126) 2095802-001-589110, 127) 2095802-001-589168, 128) 2095802-001-589304, 129) 2095802-001-589326, 130) 2095802-001-589329, 131) 2095802-001-589511, 132) 2095802-001-589655, 133) 2095802-001-589796, 134) 2095802-001-589799, 135) 2095802-001-589801, 136) 2095802-001-589993, 137) 2095802-001-590263, 138) 2095802-001-590270, 139) 2095802-001-590640, 140) 2095802-001-590643, 141) 2095802-001-590645, 142) 2095802-001-590648, 143) 2095802-001-590649, 144) 2095802-001-590651, 145) 2095802-001-590652, 146) 2095802-001-591048, 147) 2095802-001-591102, 148) 2095802-001-591244, 149) 2095802-001-591246, 150) 2095802-001-591718, 151) 2095802-001-592666, 152) 2095802-001-592669, 153) 2095802-001-592683, 154) 2095802-001-592983, 155) 2095802-001-593000, 156) 2095802-001-593024, 157) 2095802-001-593039,

Publicado el 3 de julio de 2024 · Inicio del retiro: 5 de abril de 2024

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

GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante: GE Healthcare Finland Oy
Distribuidor: Worldwide distribution.
Lote: a) model MBC303: 1) 2078633-001, UDI/DI none, Serial Numbers: 2293663-1-1; 2) 2078633-010, UDI/DI none, Serial Numbers: 2284163-2-1, 2284112-3-1, 2284163-1-1, 2284112-4-1, 2262484-1-1, 2262484-1-2; 3) 2078633-012, UDI/DI none, Serial Numbers: 2400553-4-1, 2266860-3-2; 4) 2078633-017, UDI/DI none, Serial Numbers: 2261264-2-1, 2290421-2-1, 2288663-1-1, 2290422-2-1, 2312000-3-1, 2311672-4-1, 2311672-5-1, 2320320-1-1, 2284038-3-1, 2329280-2-1; 5) 2078633-028, UDI/DI none, Serial Numbers: 2426418-2-1, 2450634-2-1, 2501447-2-1, 2426426-25-1, 2428347-1-1, 2460598-2-1, 2405070-10-1, 2426421-3-1, 2460618-6-1, 2583610-13-1, 2426425-5-1, 2428332-1-1, 2428345-1-1, 2460628-7-1, 2403419-9-1, 2426423-4-1, 2501439-13-1, 2409922-12-1, 2423627-1-1, 2460617-1-1, 2501399-4-1, 2501446-13-1, 2445364-1-1, 2465141-1-1; 6) 2095802-001-54069330, UDI/DI 00840682136723, Serial Numbers: SNR19110001HA, SNR19110005HA, SNR19110002HA, SNR19110003HA, SNR19110004HA; 7) 2095802-001-554922, UDI/DI 00840682136723, Serial Numbers: SNR18060001HA, SNR18060003HA, SNR18060005HA, SNR18060006HA, SNR18060007HA, SNR18060012HA, SNR18060013HA, SNR18060014HA, SNR18060015HA, SNR18060016HA, SNR18060017HA, SNR18010010HA, SNR18010012HA, SNR18010021HA; 8) 2095802-001-554923, UDI/DI 00840682136723, Serial Numbers: SNR18060011HA, SNR18060022HA, SNR18060028HA, SNR18060029HA, SNR18060031HA, SNR18060032HA, SNR18060036HA, SNR18070001HA, SNR18070003HA, SNR18070008HA, SNR18070012HA, SNR18070013HA, SNR18070014HA, SNR18070018HA, SNR18070019HA, SNR18070020HA, SNR18070021HA, SNR18070022HA, SNR18070023HA, SNR18070024HA, SNR18070025HA, SNR18070026HA, SNR18070027HA, SNR18070028HA, SNR18070029HA, SNR18070030HA, SNR18070031HA, SNR18070032HA, SNR18070033HA, SNR18070037HA, SNR18070038HA, SNR18070039HA, SNR18070040HA, SNR18070045HA, SNR18070046HA, SNR18070052HA, SNR19030080HA, SNR19030081HA, SNR19030082HA, SNR19030083HA, SNR19030084HA, SNR19030091HA, SNR19040002HA, SNR19040003HA, SNR19040004HA, SNR19040005HA, SNR19040006HA, SNR19040007HA, SNR18070007HA, SNR18080007HA, SNR18370013HA, SNR18070016HA, SNR18070017HA, SNR19030085HA; 9) 2095802-001-554924, UDI/DI 00840682136723, Serial Numbers: SNR18010004HA, SNR18010011HA, SNR18020001HA; 10) 2095802-001-554925, UDI/DI 00840682136723, Serial Numbers: SNR18070076HA, SNR18070077HA, SNR18070078HA, SNR18070079HA, SNR18070080HA, SNR18070081HA, SNR18070082HA, SNR18070083HA, SNR18070084HA, SNR18070085HA, SNR18070086HA, SNR18070089HA, SNR18070090HA, SNR18080001HA, SNR18080002HA, SNR18080003HA, SNR18390025HA, SNR18390027HA, SNR18400032HA, SNR18400033HA, SNR18400035HA, SNR18400037HA, SNR18400045HA, SNR18400046HA, SNR18400047HA, SNR18400053HA, SNR18400066HA, SNR19190046HA, SNR19190047HA, SNR19190048HA, SNR19190049HA, SNR19190050HA, SNR19190051HA, SNR19190052HA, SNR19190053HA, SNR18010001HA, SNR18010003HA, SNR18010013HA, SNR18010014HA, SNR18010020HA, SNR18010028HA, SNR18010029HA, SNR18020002HA; 11) 2095802-001-554926, UDI/DI 00840682136723, Serial Numbers: SNR18060002HA, SNR18060008HA, SNR18060009HA, SNR18060010HA, SNR18060018HA, SNR18060019HA, SNR18060020HA, SNR18060021HA, SNR18060023HA, SNR18060024HA, SNR18060025HA, SNR18060026HA, SNR18060027HA, SNR18060030HA, SNR18060033HA, SNR18060034HA, SNR18060035HA, SNR18070002HA, SNR18070005HA, SNR18070006HA, SNR18070009HA, SNR18070010HA, SNR18070011HA, SNR19030086HA, SNR19030087HA, SNR19030088HA, SNR19030089HA, SNR19030090HA, SNR19030092HA, SNR19030093HA, SNR19030094HA, SNR19030095HA, SNR19030096HA, SNR19030097HA, SNR19030098HA, SNR19030099HA, SNR19030100HA, SNR19030101HA, SNR19030102HA, SNR19030103HA, SNR19040019HA, SNR19040037HA, SNR19040038HA, SNR19040039HA, SNR19040050HA, SNR19040051HA, SNR18010002HA, SNR18010005HA, SNR18010009HA, SNR18010018HA, SNR18010027HA; 12) 2095802-001-554927, UDI/DI 00840682136723, Serial Numbers: SNR18010006HA, SNR18010023HA, SNR18010024HA, SNR18010025HA, SNR18010026HA, SNR18010016HA; 13) 2095802-001-554928, UDI/DI 00840682136723, Serial Numbers: SNR18070041H
Clasificación de riesgo: Class II
Área (FDA): device
País: Finland

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