Class 2 Device Recall CARESCAPE R860

• Date Initiated by Firm: July 14, 2020
• Date Posted: August 24, 2020
• Recall Status: Completed
• Recall Number: Z-2883-2020
• Recall Event ID: 86107
• 510(K)Number: K142679
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
• Code Information: CARESCAPE R860: 1506-8600-000 Spare parts: CARESCAPE R860: 1505-3215-000, 2071409-S, 2071410-001 Engstrom: M1115997-S, M1081816-S Identifier # CBRZ03152, CBRZ03159, CBRZ03171, CBRZ03173, CBRZ03174, CBRZ03175, CBRZ03176, CBRZ03177, CBRZ03180, CBRZ03182, CBRZ03867, CBRZ03869, CBRZ03870, CBRZ03873, CBRZ03856, CBRZ03259, CBRZ03261, CBRZ03263, CBRZ03264; ; CBRZ03265, CBRZ03267, CBRZ03274, CBRZ03275, CBRZ03278, CBRZ03281, CBRZ03928, CBRZ03946, CBRZ03989, CBRZ03990, CBRZ03994, CBRZ03845, CBRZ03857, CBRZ03858, CBRZ03861, CBRZ03868, CBRZ03872, CBRZ03879, CBRZ03880, CBRZ03881, CBRZ03883, CBRZ03889, CBRZ03890, CBRZ03891, CBRZ03484, CBRZ03485, CBRZ03487, CBRZ03488, CBRZ03490, CBRZ03502, CBRZ03793, CBRZ03842, CBRZ03843, CBRZ03849, CBRZ03850, CBRZ03851, CBRZ03853, CBRZ03864, CBRZ03865, CBRZ03866, CBRZ03438, CBRZ03501, CBRZ03503, CBRZ03506, CBRZ03508, CBRZ03609, CBRZ03610, CBRZ03620, CBRZ03621, CBRZ03625, CBRZ03342, CBRZ03437, CBRZ03451, CBRZ03724, CBRZ03730, CBRZ03731, CBRZ03732, CBRZ03733, CBRZ03734, CBRZ03759, CBRZ03767, CBRZ03768, CBRZ03769, CBRZ03771, CBRZ03772, CBRZ03773, CBRZ03774, CBRZ03775, CBRZ03776, CBRZ03777, CBRZ03778, CBRZ03779, CBRZ03780, CBRZ03781, CBRZ03782, CBRZ03783, CBRZ03784, CBRZ03785, CBRZ03786, CBRZ03787, CBRZ03788, CBRZ03789, CBRZ03791, CBRZ03792, CBRZ03794, CBRZ03795, CBRZ03796, CBRZ03797, CBRZ03798, CBRZ03799, CBRZ03800, CBRZ03801, CBRZ03802, CBRZ03803, CBRZ03804, CBRZ03805, CBRZ03806, CBRZ03807, CBRZ03808, CBRZ03809, CBRZ03810, CBRZ03812, CBRZ03813, CBRZ03815, CBRZ03816, CBRZ03817, CBRZ03819, CBRZ03821, CBRZ03822, CBRZ03823, CBRZ03824, CBRZ03825, CBRZ03826, CBRZ03827, CBRZ03828, CBRZ03829, CBRZ03830, CBRZ03831, CBRZ03832, CBRZ03834, CBRZ03835, CBRZ03836, CBRZ03837, CBRZ03838, CBRZ03839, CBRZ03841, CBRZ03877, CBRZ03913, CBRZ03925, CBRZ03949, CBRZ03951, CBRZ03952, CBRZ03954, CBRZ03955, CBRZ03956, CBRZ03957, CBRZ03958, CBRZ03959, CBRZ03961, CBRZ03962, CBRZ03979, CBRZ03984, CBRZ03985, CBRZ03997, CBRZ03998, CBRZ04001, CBRZ04003, CBRZ04006, CBRZ04008, CBRZ04009, CBRZ04011, CBRZ04020, CBRZ04025, CBRZ04036, CBRZ04038, CBRZ04039, CBRZ04040, CBRZ04041, CBRZ04042, CBRZ04043, CBRZ04046, CBRZ04047, CBRZ04050, CBRZ04051, CBRZ04052, CBRZ04053, CBRZ04054, CBRZ04057, CBRZ04058, CBRZ04059, CBRZ04061, CBRZ04062, CBRZ04063, CBRZ04064, CBRZ04065, CBRZ04066, CBRZ04067, CBRZ04068, CBRZ04069, CBRZ04070, CBRZ04071, CBRZ04072, CBRZ04073, CBRZ04074, CBRZ04075, CBRZ04076, CBRZ04078, CBRZ04080, CBRZ04081, CBRZ04082, CBRZ04083, CBRZ04084, CBRZ04085, CBRZ04086, CBRZ04087, CBRZ04088, CBRZ04089, CBRZ04090, CBRZ04091, CBRZ04092, CBRZ04093, CBRZ04094, CBRZ04095, CBRZ04096, CBRZ04097, CBRZ04098, CBRZ04099, CBRZ04100, CBRZ04101, CBRZ04102, CBRZ04103, CBRZ04104, CBRZ04105, CBRZ04106, CBRZ04107, CBRZ04108, CBRZ04109, CBRZ04110, CBRZ04111, CBRZ04112, CBRZ04113, CBRZ04115, CBRZ04116, CBRZ04117, CBRZ04118, CBRZ04119, CBRZ04120, CBRZ04121, CBRZ04122, CBRZ04123, CBRZ04124, CBRZ04130, CBRZ04137, CBRZ04139, CBRZ04196, CBRZ04212, CBRZ04269, CBRZ04273, CBRZ04330, CBRZ04336, CBRZ04373, CBRZ04374, CBRZ04376, CBRZ04377, CBRZ04378, CBRZ04379, CBRZ04380, CBRZ04387, CBRZ04389, CBRZ04438, CBRZ04446, CBRZ04447, CBRZ04449, CBRZ04450, CBRZ04485, CBRZ04491, CBRZ04506, CBRZ04511, CBRZ04524, CBRZ04649, CBRZ04684, CBRZ04692, CBRZ04693, CBRZ04694, CBRZ04695, CBRZ04696, CBRZ04698, CBRZ04699, CBRZ04700, CBRZ04701, CBRZ04702, CBRZ04703, CBRZ04704, CBRZ04705, CBRZ04706, CBRZ04707, CBRZ04708, CBRZ04709, CBRZ04710, CBRZ04711, CBRZ04712, CBRZ04713, CBRZ04714, CBRZ04715, CBRZ04716, CBRZ04717, CBRZ04718, CBRZ04719, CBRZ04720, CBRZ04721, CBRZ04722, CBRZ04723, CBRZ04724, CBRZ04725, CBRZ04726, CBRZ04727, CBRZ04728, CBRZ04729, CBRZ04730, CBRZ04731, CBRZ04733, CBRZ04734, CBRZ04735, CBRZ04736, CBRZ04737, CBRZ04738, CBRZ04739, CBRZ04740, CBRZ04741, CBRZ04742, CBRZ04743, CBRZ04744, CBRZ04745, CBRZ04746, CBRZ04747, CBRZ04748, CBRZ04749, CBRZ04750, CBRZ04751, CBRZ04752, CBRZ04753, CBRZ04754, CBRZ04755, CBRZ04759, CBRZ04762, CBRZ04770, CBRZ04772, CBRZ04778, CBRZ04779, CBRZ04788, CBRZ04790, CBRZ04791, CBRZ04800, CBRZ04813, CBRZ04814, CBRZ04815, CBRZ04816, CBRZ04817, CBRZ04818, CBRZ04819, CBRZ04820, CBRZ04821, CBRZ04822, CBRZ04823, CBRZ04824, CBRZ04825, CBRZ04826, CBRZ04827, CBRZ04828, CBRZ04829, CBRZ04830, CBRZ04831, CBRZ04832, CBRZ04833, CBRZ04834, CBRZ04837,CBRZ04838, CBRZ04839, CBRZ04840, CBRZ04841, CBRZ04842, CBRZ04843, CBRZ04847, CBRZ04848, CBRZ04849, CBRZ04850, CBRZ04851, CBRZ04852, CBRZ04853, CBRZ04854, CBRZ04855, CBRZ04856, CBRZ04857, CBRZ04859, CBRZ04860, CBRZ04861, CBRZ04862, CBRZ04863, CBRZ04864, CBRZ04865, CBRZ04866, CBRZ04867, CBRZ04868, CBRZ04869, CBRZ04870, CBRZ04871, CBRZ04872, CBRZ04873, CBRZ04874, CBRZ04875, CBRZ04876, CBRZ04877, CBRZ04878, CBRZ04879, CBRZ04880, CBRZ04881, CBRZ04882, CBRZ04883, CBRZ04884, CBRZ04885, CBRZ04886, CBRZ04887, CBRZ04888, CBRZ04889, CBRZ04890, CBRZ04891, CBRZ04892, CBRZ04893, CBRZ04894, CBRZ04895, CBRZ04897, CBRZ04898, CBRZ04899, CBRZ04900, CBRZ04901, CBRZ04902, CBRZ04903, CBRZ04904, CBRZ04905, CBRZ04906, CBRZ04907, CBRZ04908, CBRZ04909, CBRZ04910, CBRZ04911, CBRZ04912, CBRZ04913, CBRZ04914, CBRZ04915, CBRZ04917, CBRZ04918, CBRZ04919, CBRZ04920, CBRZ04921, CBRZ04922, CBRZ04923, CBRZ04924, CBRZ04925, CBRZ04927, CBRZ04928, CBRZ04929, CBRZ04930, CBRZ04931, CBRZ04932, CBRZ04933, CBRZ04934, CBRZ04935, CBRZ04936, CBRZ04947, CBRZ04951, CBRZ05012, CBRZ05013, CBRZ05014, CBRZ05015, CBRZ05016, CBRZ05017, CBRZ05018, CBRZ05019, CBRZ05020, CBRZ05021, CBRZ05022, CBRZ05023, CBRZ05024, CBRZ05025, CBRZ05026, CBRZ05027, CBRZ05028, CBRZ05029, CBRZ05030, CBRZ05031, CBRZ05032, CBRZ05033, CBRZ05034, CBRZ05035, CBRZ05036, CBRZ05037, CBRZ05038, CBRZ05039, CBRZ05040, CBRZ05041, CBRZ05042, CBRZ05043, CBRZ05044, CBRZ05045, CBRZ05046, CBRZ05047, CBRZ05048, CBRZ05049, CBRZ05050, CBRZ05051,CBRZ05052, CBRZ05053, CBRZ05054, CBRZ05055, CBRZ05056, CBRZ05057, CBRZ05058, CBRZ05059, CBRZ05060, CBRZ05061, CBRZ05062, CBRZ05063, CBRZ05064, CBRZ05065, CBRZ05066, CBRZ05067, CBRZ05068, CBRZ05069, CBRZ05070, CBRZ05071, CBRZ05072, CBRZ05073, CBRZ05074, CBRZ05075, CBRZ05076, CBRZ05077, CBRZ05078, CBRZ05079, CBRZ05080, CBRZ05081, CBRZ05082, CBRZ05083, CBRZ05084, CBRZ05085, CBRZ05086, CBRZ05087, CBRZ05088, CBRZ05089, CBRZ05090, CBRZ05091, CBRZ05092, CBRZ05093, CBRZ05094, CBRZ05095, CBRZ05096, CBRZ05097, CBRZ05098, CBRZ05099, CBRZ05100, CBRZ05101, CBRZ05102, CBRZ05103, CBRZ05106, CBRZ05107, CBRZ05108, CBRZ05109, CBRZ05110, CBRZ05111, CBRZ05112, CBRZ05113 CBRZ05114, CBRZ05115, CBRZ05116, CBRZ05117, CBRZ05118, CBRZ05119, CBRZ05120, CBRZ05121, CBRZ05122, CBRZ05123, CBRZ05124, CBRZ05125, CBRZ05126, CBRZ05127, CBRZ05128, CBRZ05129, CBRZ05130, CBRZ05131, CBRZ05132, CBRZ05133, CBRZ05134, CBRZ05135, CBRZ05136, CBRZ05137, CBRZ05138, CBRZ05139, CBRZ05140, CBRZ05141, CBRZ05142, CBRZ05143, CBRZ05144, CBRZ05145, CBRZ05146, CBRZ05147, CBRZ05148, CBRZ05149, CBRZ05150, CBRZ05151, CBRZ05152, CBRZ05154, CBRZ05153, CBRZ05155, CBRZ05156, CBRZ05157, CBRZ05158, CBRZ05159, CBRZ05160, CBRZ05161, CBRZ05162, CBRZ05163, CBRZ05164, CBRZ05165, CBRZ05166, CBRZ05167, CBRZ05168, CBRZ05169, CBRZ05170, CBRZ05171, CBRZ05172, CBRZ05173, CBRZ05174, CBRZ05175, CBRZ05176, CBRZ05177, CBRZ05178 CBRZ05179, CBRZ05180, CBRZ05181, CBRZ05182, CBRZ05183, CBRZ05184, CBRZ05185, CBRZ05186, CBRZ05187, CBRZ05188, CBRZ05189, CBRZ05190, CBRZ05191, CBRZ05192, CBRZ05193, CBRZ05194, CBRZ05195, CBRZ05196, CBRZ05197, CBRZ05198, CBRZ05199, CBRZ05200, CBRZ05201, CBRZ05202, CBRZ05203, CBRZ05204, CBRZ05205, CBRZ05206, CBRZ05207, CBRZ05208, CBRZ05209, CBRZ05210, CBRZ05211, CBRZ05212, CBRZ05213, CBRZ05214, CBRZ05215, CBRZ05216, CBRZ05217, CBRZ05218, CBRZ05219, CBRZ05220, CBRZ05221, CBRZ05222, CBRZ05223, CBRZ05224, CBRZ05225, CBRZ05226, CBRZ05227, CBRZ05228, CBRZ05229, CBRZ05230, CBRZ05231, CBRZ05232, CBRZ05233, CBRZ05234, CBRZ05235, CBRZ05236, CBRZ05237, CBRZ05238, CBRZ05239, CBRZ05241, CBRZ05242, CBRZ05244, CBRZ05245, CBRZ05247, CBRZ05248, CBRZ05249, CBRZ05252, CBRZ05255, CBRZ05256, CBRZ05257, CBRZ05258, CBRZ05259, CBRZ05260, CBRZ05261, CBRZ05262, CBRZ05263, CBRZ05264, CBRZ05265, CBRZ05266, CBRZ05267, CBRZ05268, CBRZ05273, CBRZ05276, CBRZ05277, CBRZ05278, CBRZ05279, CBRZ05280, CBRZ05281, CBRZ05282, CBRZ05283, CBRZ05284, CBRZ05285, CBRZ05286, CBRZ05287, CBRZ05288, CBRZ05289, CBRZ05290, CBRZ05291, CBRZ05292, CBRZ05294, CBRZ05295, CBRZ05296, CBRZ05302, CBRZ05303, CBRZ05304, CBRZ05305, CBRZ05306, CBRZ05309, CBRZ05311, CBRZ05312, CBRZ05313, CBRZ05314 CBRZ05315, CBRZ05317, CBRZ05318, CBRZ05319, CBRZ05320, CBRZ05321, CBRZ05322, CBRZ05323, CBRZ05324, CBRZ05326, CBRZ05327, CBRZ05328, CBRZ05329, CBRZ05330 CBRZ05331, CBRZ05332, CBRZ05333, CBRZ05334, CBRZ05335, CBRZ05340, CBRZ40010, CBRZ40038, CBRZ40039, CBRZ40040, CBRZ03469, CBRZ03504, CBRZ03505, CBRZ03510, CBRZ03513, CBRZ03514, CBRZ03515, CBRZ03516, CBRZ03517, CBRZ03518, CBRZ03522, CBRZ03523, CBRZ03526, CBRZ03531, CBRZ03532, CBRZ03533, CBRZ03534, CBRZ03535, CBRZ03536, CBRZ03537, CBRZ03538, CBRZ03539, CBRZ03540, CBRZ03541, CBRZ03543, CBRZ03544, CBRZ03548, CBRZ03550, CBRZ03552, CBRZ02183, CBRZ03110, CBRZ03128, CBRZ03130, CBRZ03131, CBRZ03132, CBRZ03133, CBRZ03134, CBRZ03135, CBRZ03136, CBRZ03137, CBRZ03138, CBRZ03139, CBRZ03140, CBRZ03141, CBRZ03142, CBRZ03143, CBRZ03144, CBRZ03145, CBRZ03146, CBRZ03147, CBRZ03148, CBRZ03149, CBRZ03150, CBRZ03151, CBRZ03153, CBRZ03154, CBRZ03156, CBRZ03158, CBRZ03160, CBRZ03161, CBRZ03163, CBRZ03164, CBRZ03165, CBRZ03167, CBRZ03170, CBRZ03185, CBRZ03188, CBRZ03202, CBRZ03206, CBRZ03208, CBRZ03209, CBRZ03210, CBRZ03211, CBRZ03212, CBRZ03213, CBRZ03214, CBRZ03215, CBRZ03216, CBRZ03217, CBRZ03218, CBRZ03219, CBRZ03220, CBRZ03221, CBRZ03222, CBRZ03223, CBRZ03226, CBRZ03227, CBRZ03228, CBRZ03229, CBRZ03230, CBRZ03232, CBRZ03234, CBRZ03236, CBRZ03237, CBRZ03238, CBRZ03239, CBRZ03240, CBRZ03241, CBRZ03242, CBRZ03243, CBRZ03244, CBRZ03245, CBRZ03246, CBRZ03247, CBRZ03248, CBRZ03249, CBRZ03250, CBRZ03251, CBRZ03252, CBRZ03253, CBRZ03254, CBRZ03255, CBRZ03256, CBRZ03258, CBRZ03262, CBRZ03269, CBRZ03270, CBRZ03271, CBRZ03272, CBRZ03273, CBRZ03277, CBRZ03279, CBRZ03280, CBRZ03283, CBRZ03286, CBRZ03287, CBRZ03288, CBRZ03289, CBRZ03290, CBRZ03291, CBRZ03292, CBRZ03293, CBRZ03294, CBRZ03295, CBRZ03296, CBRZ03297, CBRZ03298, CBRZ03299, CBRZ03300,CBRZ03301, CBRZ03302, CBRZ03303, CBRZ03304, CBRZ03305, CBRZ03306, CBRZ03307, CBRZ03308, CBRZ03309, CBRZ03310, CBRZ03311, CBRZ03315, CBRZ03317, CBRZ03318, CBRZ03319, CBRZ03320, CBRZ03321, CBRZ03322, CBRZ03323, CBRZ03324, CBRZ03325, CBRZ03326 ,CBRZ03327, CBRZ03329, CBRZ03330, CBRZ03331, CBRZ03332, CBRZ03333, CBRZ03334, CBRZ03335, CBRZ03336, CBRZ03337, CBRZ03338, CBRZ03339, CBRZ03340, CBRZ03341, CBRZ03343, CBRZ03344, CBRZ03345, CBRZ03346, CBRZ03347, CBRZ03348, CBRZ03349, CBRZ03350, CBRZ03351, CBRZ03352, CBRZ03353, CBRZ03354, CBRZ03355, CBRZ03356, CBRZ03357, CBRZ03358, CBRZ03359, CBRZ03360, CBRZ03361, CBRZ03362, CBRZ03363, CBRZ03364, CBRZ03365, CBRZ03366, CBRZ03367, CBRZ03368, CBRZ03369, CBRZ03370, CBRZ03371, CBRZ03372, CBRZ03373, CBRZ03374, CBRZ03375, CBRZ03376, CBRZ03377, CBRZ03378, CBRZ03379, CBRZ03380, CBRZ03381, CBRZ03382, CBRZ03383, CBRZ03384, CBRZ03385, CBRZ03386, CBRZ03387, CBRZ03388, CBRZ03389, CBRZ03390, CBRZ03391, CBRZ03392, CBRZ03393, CBRZ03394, CBRZ03395, CBRZ03396, CBRZ03397, CBRZ03398, CBRZ03399, CBRZ03400, CBRZ03401, CBRZ03402, CBRZ03403, CBRZ03404, CBRZ03405, CBRZ03406, CBRZ03407, CBRZ03408, CBRZ03409, CBRZ03410, CBRZ03411, CBRZ03412, CBRZ03413, CBRZ03414, CBRZ03415, CBRZ03416, CBRZ03417, CBRZ03418, CBRZ03419, CBRZ03420, CBRZ03421, CBRZ03422, CBRZ03423, CBRZ03424, CBRZ03425, CBRZ03426, CBRZ03428, CBRZ03429, CBRZ03430, CBRZ03431, CBRZ03432, CBRZ03433, CBRZ03434, CBRZ03435, CBRZ03436, CBRZ03439, CBRZ03440, CBRZ03441, CBRZ03442, CBRZ03443, CBRZ03444, CBRZ03445, CBRZ03446, CBRZ03447, CBRZ03448, CBRZ03449, CBRZ03450, CBRZ03452, CBRZ03453, CBRZ03454, CBRZ03455, CBRZ03456, CBRZ03457, CBRZ03458, CBRZ03459, CBRZ03460, CBRZ03461, CBRZ03462, CBRZ03463, CBRZ03464, CBRZ03465, CBRZ03466, CBRZ03467, CBRZ03468 CBRZ03470, CBRZ03471, CBRZ03473, CBRZ03474, CBRZ03475, CBRZ03476, CBRZ03479, CBRZ03480, 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CBRZ03988, CBRZ03947, CBRZ03950, CBRZ03980, CBRZ03987, CBRZ03622, CBRZ03623, CBRZ03624, CBRZ03629, CBRZ03630, CBRZ03427, CBRZ03482, CBRZ03483, CBRZ03492, CBRZ03494, CBRZ03742, CBRZ03705, CBRZ03708, CBRZ03710, CBRZ03715, CBRZ03073, CBRZ03074, CBRZ03076, CBRZ03080, CBRZ03082.
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE Healthcare Service; 800-437-1171
• Manufacturer Reason for Recall: The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
• FDA Determined Cause: Process control
• Action: On July 14th, 2020 the firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 7/14/2020 to its customers with the following instructions: Safety Instructions You may continue to use the CARESCAPE R860 Ventilator. Ensure that the FiO2 alarm limit is set to the factory default limit +/- 6 % so that the clinician is aware if the measured value differs from set value. When making an extubation decision, use the set FiO2 value instead of the FiO2 measured by the oxygen sensor. The user can use other methods to measure FiO2 or switch to another device and call GE Healthcare. Product Correction: GE Healthcare will correct all affected units at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. Contact Information: If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
• Quantity in Commerce: 2277 units
• Distribution: Domestic Distribution: USA International Distribution: Australia, Bahrain, Bermuda, Canada, Egypt, France, Germany, Honduras, India, Iraq, Italy, Lebanon, Mexico, Panama, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Taiwan and United Arab Emirates.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• 510(K) Database: 510(K)s with Product Code = CBK