GE Healthcare, LLC: 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.

Recall number

Z-2883-2020

Recalling firm

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.

Status

Terminated

Initiated

2020-07-14

Posted

2020-08-24

Terminated

2024-09-23

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.

Root 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

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.

Lot, serial or model codes

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, 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CBRZ04287, CBRZ04288, CBRZ04289, CBRZ04290, CBRZ04291, CBRZ04292, CBRZ04293, CBRZ04294, CBRZ04295, CBRZ04296, CBRZ04297, CBRZ04298, CBRZ04299, CBRZ04300, CBRZ04301, CBRZ04302, CBRZ04303, CBRZ04304, CBRZ04305, CBRZ04306, CBRZ04307, CBRZ04308, CBRZ04309, CBRZ04310, CBRZ04311, CBRZ04312, CBRZ04313, CBRZ04314, CBRZ04315, CBRZ04316, CBRZ04317, CBRZ04318, CBRZ04319, CBRZ04320, CBRZ04321, CBRZ04322, CBRZ04323, CBRZ04324, CBRZ04325, CBRZ04326, CBRZ04327, CBRZ04328, CBRZ04329, CBRZ04331, CBRZ04332, CBRZ04333, CBRZ04334, CBRZ04335, CBRZ04337, CBRZ04338, CBRZ04339, CBRZ04340, CBRZ04341, CBRZ04343, CBRZ04344, CBRZ04345, CBRZ04346, CBRZ04347, CBRZ04348, CBRZ04349, CBRZ04350, CBRZ04351, CBRZ04352, CBRZ04353, CBRZ04354, CBRZ04355, CBRZ04356, CBRZ04357, CBRZ04358, CBRZ04359, CBRZ04365, CBRZ04366, CBRZ04367, CBRZ04368, CBRZ04369, CBRZ04370, CBRZ04371, CBRZ04372, CBRZ04375, CBRZ04381, CBRZ04382, CBRZ04383, CBRZ04384, CBRZ04385, CBRZ04386, CBRZ04388, CBRZ04390, CBRZ04391, CBRZ04392, CBRZ04393, CBRZ04394, CBRZ04395, CBRZ04396, CBRZ04397, CBRZ04398, CBRZ04399, CBRZ04400, CBRZ04401, CBRZ04402, CBRZ04403, CBRZ04404, CBRZ04405, CBRZ04406, CBRZ04407, CBRZ04408, CBRZ04409, CBRZ04410, CBRZ04411, CBRZ04412, CBRZ04413, CBRZ04414, CBRZ04415, CBRZ04416, CBRZ04417, CBRZ04418, CBRZ04419, CBRZ04420, CBRZ04421, CBRZ04422, CBRZ04423, CBRZ04424, CBRZ04425, CBRZ04426, CBRZ04427, CBRZ04428, CBRZ04429, CBRZ04430, CBRZ04431, CBRZ04432, CBRZ04433, CBRZ04434, CBRZ04435, CBRZ04436, CBRZ04437, CBRZ04439, CBRZ04440, CBRZ04441, CBRZ04442, CBRZ04443, CBRZ04444, CBRZ04445, CBRZ04448, CBRZ04451, CBRZ04452, CBRZ04453, CBRZ04454, CBRZ04455, CBRZ04456, CBRZ04457, CBRZ04458, CBRZ04459, CBRZ04460, CBRZ04461, CBRZ04462, CBRZ04463, CBRZ04464, CBRZ04465, CBRZ04466, CBRZ04467, CBRZ04468, CBRZ04469, CBRZ04470, CBRZ04471, CBRZ04472, CBRZ04473, CBRZ04474, CBRZ04475, CBRZ04476, CBRZ04477, CBRZ04478, CBRZ04479, CBRZ04480, CBRZ04481, CBRZ04482, CBRZ04483, CBRZ04484, CBRZ04486, CBRZ04487, CBRZ04488, CBRZ04489, CBRZ04490, CBRZ04492, 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CBRZ04587, CBRZ04588, CBRZ04589, CBRZ04590, CBRZ04591, CBRZ04592, CBRZ04593, CBRZ04594, CBRZ04595, CBRZ04596, CBRZ04597, CBRZ04598, CBRZ04599, CBRZ04600, CBRZ04601, CBRZ04602, CBRZ04603, CBRZ04604, CBRZ04605, CBRZ04606, CBRZ04607, CBRZ04608, CBRZ04609, CBRZ04610, CBRZ04611, CBRZ04612, CBRZ04613, CBRZ04614, CBRZ04615, CBRZ04616, CBRZ04617, CBRZ04618, CBRZ04619, CBRZ04620, CBRZ04621, CBRZ04622, CBRZ04623, CBRZ04624, CBRZ04625, CBRZ04626, CBRZ04627, CBRZ04628, CBRZ04629, CBRZ04630, CBRZ04631, CBRZ04632, CBRZ04633, CBRZ04634, CBRZ04635, CBRZ04636, CBRZ04637, CBRZ04638, CBRZ04639, CBRZ04640, CBRZ04641, CBRZ04642, CBRZ04643, CBRZ04644, CBRZ04645, CBRZ04646, CBRZ04647, CBRZ04648, CBRZ04650, CBRZ04651, CBRZ04652, CBRZ04653, CBRZ04654, CBRZ04655, CBRZ04656, CBRZ04657, CBRZ04658, CBRZ04659, CBRZ04660, CBRZ04661, CBRZ04662, CBRZ04663, CBRZ04664, CBRZ04665, CBRZ04666, CBRZ04667, CBRZ04668, CBRZ04669, CBRZ04670, CBRZ04671, CBRZ04672, CBRZ04673, CBRZ04674, CBRZ04675, CBRZ04676, CBRZ04677, CBRZ04678, 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CBRZ03950, CBRZ03980, CBRZ03987, CBRZ03622, CBRZ03623, CBRZ03624, CBRZ03629, CBRZ03630, CBRZ03427, CBRZ03482, CBRZ03483, CBRZ03492, CBRZ03494, CBRZ03742, CBRZ03705, CBRZ03708, CBRZ03710, CBRZ03715, CBRZ03073, CBRZ03074, CBRZ03076, CBRZ03080, CBRZ03082.

510(k) numbers

["K142679"]

PMA numbers

not on file

Product code

CBK

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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