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GE Healthcare Finland Oy

FDA Regulatory Profile

Summary

Total Recalls
22 (9 Class I)
510(k) Clearances
30
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0455-2026Class IIB105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6September 26, 2025
Z-0453-2026Class IICarescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batterieSeptember 26, 2025
Z-0454-2026Class IICARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteSeptember 26, 2025
Z-0456-2026Class IIPortrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia DetectionSeptember 26, 2025
Z-0457-2026Class IIBATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-September 26, 2025
Z-2168-2024Class IICARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) April 5, 2024
Z-2169-2024Class IICARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitApril 5, 2024
Z-2170-2024Class IICARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-0105April 5, 2024
Z-2172-2024Class IICARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 20April 5, 2024
Z-2171-2024Class IICARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-010184April 5, 2024
Z-2032-2023Class ITruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(May 19, 2023
Z-2030-2023Class ITruSignal Ear Sensor, REF TS-E-D; OximeterMay 19, 2023
Z-2027-2023Class ITruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; OximeterMay 19, 2023
Z-2028-2023Class ITruSignal Sensitive Skin Sensor, REF TS-SE-3; OximeterMay 19, 2023
Z-2029-2023Class ITruSignal Wrap Sensor, REF TS-W-D; OximeterMay 19, 2023
Z-2033-2023Class ITruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; OximeterMay 19, 2023
Z-2034-2023Class ITruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; OximeterMay 19, 2023
Z-2031-2023Class ITruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, EarMay 19, 2023
Z-2026-2023Class ITruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 May 19, 2023
Z-0095-2019Class IIGE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) coSeptember 4, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)April 6, 2023
K213336Carescape B850, E-musbApril 13, 2022
K213363CARESCAPE B450, E-musbApril 13, 2022
K213181CARESCAPE B650, E-musbApril 13, 2022
K211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOctober 21, 2021
K191323Carescape B850January 29, 2020
K191249CARESCAPE B450January 24, 2020
K191322E-EEGX, N-EEGXJanuary 22, 2020
K191149CARESCAPE B650January 21, 2020
K183394CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiOMay 1, 2019
K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessoriesAugust 17, 2017
K143676B40i Patient MonitorJuly 31, 2015
K150245CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVXJuly 17, 2015
K132528E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIESJanuary 16, 2014
K132533CARESCAPE MONITOR B450December 4, 2013
K132696TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSORSeptember 27, 2013
K131223CARESCAPE MONITOR B650August 28, 2013
K131414CARESCAPE MONITOR B850August 28, 2013
K123195CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIESFebruary 28, 2013
K103802TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSORAugust 2, 2011