FDA Device recall Z-2883-2020

CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilat…

FDA Device
Class II
terminated
Published 2020-09-02

On 2020-09-02 the FDA classified a Class II recall of CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilat… by Ge Healthcare, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2883-2020
Classification	Class II
Status	terminated
Initiated	2020-07-14
Published	2020-09-02
Last updated	2026-09-13 11:55 UTC
Company	Ge Healthcare
Distribution	n/a

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.

Identifiers

code_info	CARESCAPE R860: 1506-8600-000 Spare parts: CARESCAPE R860: 1505-3215-000, 2071409-S, 2071410-001 Engstrom: M1115997-… 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, CB

code_info

CARESCAPE R860: 1506-8600-000 Spare parts: CARESCAPE R860: 1505-3215-000, 2071409-S, 2071410-001 Engstrom: M1115997-…

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, CB

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2883-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.