Company ยท FI
GE Healthcare Finland Oy
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2026. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (2 in 12 months)
22recalls (0 in 12 months)
21recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 25 |
| DPZ | Oximeter, Ear | 9 |
| BSZ | Gas-Machine, Anesthesia | 5 |
| DQA | Oximeter | 5 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 4 |
| DQK | Computer, Diagnostic, Programmable | 3 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 1, 2026 | K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSig GE Healthcare Finland Oy, FI | MHX |
| Aug 28, 2026 | K260343 | Carescape Canvas 1000; Carescape Canvas Smart Display GE Healthcare Finland Oy, FI | MHX |
| Apr 6, 2023 | K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) GE Healthcare Finland Oy, FI | MHX |
| Apr 13, 2022 | K213363 | CARESCAPE B450, E-musb GE Healthcare Finland Oy, FI | MHX |
| Apr 13, 2022 | K213336 | Carescape B850, E-musb GE Healthcare Finland Oy, FI | MHX |
| Apr 13, 2022 | K213181 | CARESCAPE B650, E-musb GE Healthcare Finland Oy, FI | MHX |
| Oct 21, 2021 | K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories GE Healthcare Finland Oy, FI | CCK |
| Jan 29, 2020 | K191323 | Carescape B850 GE Healthcare Finland Oy, FI | MHX |
| Jan 24, 2020 | K191249 | CARESCAPE B450 GE Healthcare Finland Oy, FI | MHX |
| Jan 22, 2020 | K191322 | E-EEGX, N-EEGX GE Healthcare Finland Oy, FI | OLT |
| Jan 21, 2020 | K191149 | CARESCAPE B650 GE Healthcare Finland Oy, FI | MHX |
| May 1, 2019 | K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO GE Healthcare Finland Oy, FI | CCK |
| Aug 17, 2017 | K171028 | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories GE Healthcare Finland Oy, FI | CCK |
| Jul 31, 2015 | K143676 | B40i Patient Monitor GE Healthcare Finland Oy, FI | MHX |
| Jul 17, 2015 | K150245 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX GE Healthcare Finland Oy, FI | CCK |
| Jan 16, 2014 | K132528 | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES GE Healthcare Finland Oy, FI | DXG |
| Dec 4, 2013 | K132533 | CARESCAPE MONITOR B450 GE Healthcare Finland Oy, FI | MHX |
| Sep 27, 2013 | K132696 | TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR GE Healthcare Finland Oy | DQA |
| Aug 28, 2013 | K131414 | CARESCAPE MONITOR B850 GE Healthcare Finland Oy, FI | MHX |
| Aug 28, 2013 | K131223 | CARESCAPE MONITOR B650 GE Healthcare Finland Oy, FI | MHX |
| Feb 28, 2013 | K123195 | CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES GE Healthcare Finland Oy, FI | CCL |
| Aug 2, 2011 | K103802 | TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR GE Healthcare Finland Oy, FI | DQA |
| Jun 10, 2011 | K102389 | NAVIGATOR APPLICATIONS SUITE GE Healthcare Finland Oy | BSZ |
| Oct 18, 2010 | K102239 | CARESCAPE MONITOR B650 GE Healthcare Finland Oy, FI | MHX |
| Oct 4, 2010 | K101871 | TRUSIGNAL SPO2 FINGERTIP SENSOR GE Healthcare Finland Oy, FI | DQA |
| Mar 12, 2010 | K093881 | TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR GE Healthcare Finland Oy, FI | DQA |
| Sep 23, 2009 | K092680 | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN GE Healthcare Finland Oy, FI | MHX |
| Apr 30, 2009 | K090892 | GE DATEX-OHMEDA S/5 ADU CARESTATION GE Healthcare Finland Oy | BSZ |
| Apr 1, 2009 | K083098 | NAVIGATOR APPLICATIONS SUITE GE Healthcare Finland Oy | BSZ |
| Aug 7, 2008 | K081941 | NAVIGATOR APPLICATIONS SUITE GE Healthcare Finland Oy | BSZ |
| Jul 31, 2008 | K081870 | MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO GE Healthcare Finland Oy | DQA |
| Oct 10, 2007 | K071097 | NAVIGATOR APPLICATIONS SUITE GE Healthcare Finland Oy | BSZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | GE Healthcare Finland Oy BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS
used with affected patient monitors
Model No 2062895-001
Manufacturer Part Number U80296-1R01, revision S Open, Classified |
MHX | None listed |
| Nov 7, 2025 | GE Healthcare Finland Oy Portrait VSM
Model nos.
6660000-666
Monitor, Physiological, Patient (With
Arrhythmia Detection or Alarms Open, Classified |
MHX | K233810 |
| Nov 7, 2025 | GE Healthcare Finland Oy B105P, B125P, B105M, B125M, B155M Patient Monitors;
Model nos.
6160000-002
6160000-003
6160000-004
6160000-005
6160000-101
6160000-102
6160000-103
6160000-104
6160000-105
6160001-063
6160001-064
6160 Open, Classified |
MHX | K213490 |
| Nov 7, 2025 | GE Healthcare Finland Oy CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part
Monitor, Physiological, Patient (With
Arrhythmia Detection or Alarms Open, Classified |
MHX | K213234 |
| Nov 7, 2025 | GE Healthcare Finland Oy Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part
Monitor, Physiological, Patient (With
Arrhythmia Detection or Alarms
R Open, Classified |
MHX | K213363 |
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE B850 Model Numbers:
a) MBC303, Model Numbers:
1) 2078633-001,
2) 2078633-010,
3) 2078633-012,
4) 2078633-017,
5) 2078633-028,
6) 2095802-001-54069330,
7) 2095802-001-554922,
8) 2 Open, Classified |
MHX | K191149 K213181 |
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE B650: Model Numbers:
a) MBB313, Model Numbers:
1) 2095801-001,
2) 2095801-001-01018416,
3) 2095801-001-01023150,
4) 2095801-001-01023151,
5) 2095801-001-01023152,
6) 2095801-001-01 Open, Classified |
MHX | K191149 K213181 |
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE Canvas Smart Display, Model Numbers:
a) 5514418,
b) 5514418 / MAEP2,
c) 5514418-01059642,
d) 5514418-01080402,
e) 5514418-01081317,
f) 5514418-01086007,
g) 5514418-01086838,
h) 55 Open, Classified |
MHX | K191323 K213336 |
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE Canvas Smart Display, Model Numbers:
a) 5700023,
b) 5700023-02,
c) 5939590-102;
monitor, physiological, patient Open, Classified |
MHX | K223531 |
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE Canvas 1000, Model Numbers:
a) 5865770;
b) 5865770-01040169;
c) 5865770-01054142;
d) 5865770-01054696;
e) 5865770-01054698;
f) 5865770-01054721;
g) 5865770-01054740;
h) 5865770-0105 Open, Classified |
MHX | K223531 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter Open, Classified |
DPZ | K021955 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter Open, Classified |
DPZ | K021955 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms) Open, Classified |
DPZ | K040831 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear Open, Classified |
DPZ | K040831 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Ear Sensor, REF TS-E-D; Oximeter Open, Classified |
DPZ | K093881 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Wrap Sensor, REF TS-W-D; Oximeter Open, Classified |
DPZ | K093881 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter Open, Classified |
DPZ | K093881 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal AllFit Sensor:
a) REF TS-AF-10, 10 pcs;
B) REF AF-25, 25 pcs; Oximeter Open, Classified |
DPZ | K093881 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Adult/Pediatric Sensor; Oximeter, Ear:
a) REF TS-AP-10, 10 pcs;
b) REF TS-AP-25, 25 pcs Open, Classified |
DPZ | K040831 |
| Sep 4, 2018 | GE Healthcare Finland Oy GE Healthcare CARESCAPE Monitor B850
Product Usage:
Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monito Open, Classified |
DQK | K132533 |
| Sep 4, 2018 | GE Healthcare Finland Oy GE Healthcare CARESCAPE Monitor B450
Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for u Open, Classified |
DQK | K132533 |
| May 25, 2018 | GE Healthcare Finland Oy GE Healthcare CARESCAPE Monitor B650 Open, Classified |
DQK | K102239 K131223 |