CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based…

Date

Sept. 2, 2020

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

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.

Reason

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.

Distribution pattern

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.

Quantity

2277 units

Codes and lots

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, 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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, CBRZ03481…

Recall started

July 14, 2020

Device type

Ventilator, Continuous, Facility Use

Root cause (FDA)

Process control

What the company told customers

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.

Recall number

Z-2883-2020

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2883-2020. The agency record governs; check it and the company before acting.