Chrysalis Intelligence · Sponsors · GE Healthcare Finland Oy

GE Healthcare Finland Oy

Helsinki, FI · 11 510(k) clearances · 19 recalls (9 Class I)

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Total clearances
11
2020-01-21 → 2026-09-01
Last 12 months
2
Product codes
3
Most recent
2026-09-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Class II Cardiovascular 9 2026-09-01
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Class II Anesthesiology 1 2021-10-21
OLT Non-Normalizing Quantitative Electroencephalograph Software Class II Neurology 1 2020-01-22
Safety

Recalls (19)

Class I (serious)
9
Risk of injury / death
Total recalls
19
Currently ongoing
19
Most recent
2025-09-26
DateSeverityStatusRecall # ProductCodeReason
2025-09-26 Class II Ongoing Z-0457-2026 BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Pa… — Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up p…
2025-09-26 Class II Ongoing Z-0456-2026 Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms — Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up p…
2025-09-26 Class II Ongoing Z-0455-2026 B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-1… — Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up p…
2025-09-26 Class II Ongoing Z-0454-2026 CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a … — Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up p…
2025-09-26 Class II Ongoing Z-0453-2026 Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spa… — Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up p…
2024-04-05 Class II Ongoing Z-2172-2024 CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 20786… — GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCA…
2024-04-05 Class II Ongoing Z-2171-2024 CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-… — GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCA…
2024-04-05 Class II Ongoing Z-2170-2024 CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01… — GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCA…
2024-04-05 Class II Ongoing Z-2169-2024 CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, p… — GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCA…
2024-04-05 Class II Ongoing Z-2168-2024 CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e… — GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCA…
2023-05-19 Class I Ongoing Z-2034-2023 TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19 Class I Ongoing Z-2033-2023 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19 Class I Ongoing Z-2032-2023 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia dete… — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19 Class I Ongoing Z-2031-2023 TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19 Class I Ongoing Z-2030-2023 TruSignal Ear Sensor, REF TS-E-D; Oximeter — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19 Class I Ongoing Z-2029-2023 TruSignal Wrap Sensor, REF TS-W-D; Oximeter — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19 Class I Ongoing Z-2028-2023 TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19 Class I Ongoing Z-2027-2023 TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
2023-05-19 Class I Ongoing Z-2026-2023 TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
Filings

All 510(k) clearances (11)

Date K-number Device Code Class Specialty
2026-09-01 K260656 Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M MHX Class II Cardiovascular
2026-08-28 K260343 Carescape Canvas 1000; Carescape Canvas Smart Display MHX Class II Cardiovascular
2023-04-06 K223531 CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) MHX Class II Cardiovascular
2022-04-13 K213363 CARESCAPE B450, E-musb MHX Class II Cardiovascular
2022-04-13 K213336 Carescape B850, E-musb MHX Class II Cardiovascular
2022-04-13 K213181 CARESCAPE B650, E-musb MHX Class II Cardiovascular
2021-10-21 K211171 CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories CCK Class II Anesthesiology
2020-01-29 K191323 Carescape B850 MHX Class II Cardiovascular
2020-01-24 K191249 CARESCAPE B450 MHX Class II Cardiovascular
2020-01-22 K191322 E-EEGX, N-EEGX OLT Class II Neurology
2020-01-21 K191149 CARESCAPE B650 MHX Class II Cardiovascular
Data source: openFDA · Generated 2026-09-15 10:42 · Last ingest 2026-09-15T14:41:04.075193 · Pipeline: Chrysalis Intelligence