CARESCAPE
Model Monitor B650-LI · GE Healthcare Finland Oy · DI 00840682108379
BZK — Spirometer, Monitoring (W/Wo Alarm) · Class II · 21 CFR 868.1850
BZL — Computer, Oxygen-Uptake · Class II · 21 CFR 868.1730
BZQ — Monitor, Breathing Frequency · Class II · 21 CFR 868.2375
CAP — Monitor, Airway Pressure (Includes Gauge And/Or Alarm) · Class II · 21 CFR 868.2600
CBQ — Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500
CBR — Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) · Class II · 21 CFR 868.1700
CBS — Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) · Class II · 21 CFR 868.1620
CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase · Class II · 21 CFR 868.1400
CCL — Analyzer, Gas, Oxygen, Gaseous-Phase · Class II · 21 CFR 868.1720
DPS — Electrocardiograph · Class II · 21 CFR 870.2340
DPZ — Oximeter, Ear · Class II · 21 CFR 870.2710
DQA — Oximeter · Class II · 21 CFR 870.2700
DQK — Computer, Diagnostic, Programmable · Class II · 21 CFR 870.1425
DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) · Class II · 21 CFR 870.2300
DSI — Detector And Alarm, Arrhythmia · Class II · 21 CFR 870.1025
DSJ — Alarm, Blood-Pressure · Class II · 21 CFR 870.1100
DSK — Computer, Blood-Pressure · Class II · 21 CFR 870.1110
DXG — Computer, Diagnostic, Pre-Programmed, Single-Function · Class II · 21 CFR 870.1435
DXN — System, Measurement, Blood-Pressure, Non-Invasive · Class II · 21 CFR 870.1130
FLL — Continuous Measurement Thermometer · Class II · 21 CFR 880.2910
GWJ — Stimulator, Auditory, Evoked Response · Class II · 21 CFR 882.1900
GWQ — Full-Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400
KOI — Stimulator, Nerve, Peripheral, Electric · Class II · 21 CFR 868.2775
KRB — Probe, Thermodilution · Class II · 21 CFR 870.1915
MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.1025
MLD — Monitor, St Segment With Alarm · Class II · 21 CFR 870.1025
NHO — Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500
NHP — Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500
OLT — Non-Normalizing Quantitative Electroencephalograph Software · Class II · 21 CFR 882.1400
OLW — Index-Generating Electroencephalograph Software · Class II · 21 CFR 882.1400
OMC — Reduced- Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400
ORT — Burst Suppression Detection Software For Electroencephalograph · Class II · 21 CFR 882.1400
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (4)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2018-05-25 | Z-2340-2018 | Class II | Open, Classified | When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected. | k number procode |
| 2015-05-04 | Z-1606-2015 | Class II | Terminated | The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patients condition and delayed or missed life sustaining patient treatment | k number procode |
| 2014-06-13 | Z-2085-2014 | Class II | Terminated | Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur. | k number procode |
| 2014-02-28 | Z-1175-2014 | Class II | Terminated | GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) and Bed to Bed Issues. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 9.75 |
| 2019-02 | 0 | 8.22 |
| 2019-03 | 0 | 9.59 |
| 2019-04 | 0 | 7.07 |
| 2019-05 | 0 | 7.04 |
| 2019-06 | 0 | 6.51 |
| 2019-07 | 0 | 8.06 |
| 2019-08 | 0 | 7.12 |
| 2019-09 | 0 | 8.97 |
| 2019-10 | 0 | 7.78 |
| 2019-11 | 0 | 8.39 |
| 2019-12 | 0 | 7.81 |
| 2020-01 | 0 | 7.33 |
| 2020-02 | 0 | 7.89 |
| 2020-03 | 0 | 8.36 |
| 2020-04 | 0 | 8.22 |
| 2020-05 | 0 | 6.3 |
| 2020-06 | 0 | 6.7 |
| 2020-07 | 0 | 6.32 |
| 2020-08 | 0 | 7.47 |
| 2020-09 | 0 | 8.35 |
| 2020-10 | 0 | 7.89 |
| 2020-11 | 0 | 13.3 |
| 2020-12 | 0 | 15.56 |
| 2021-01 | 0 | 12.52 |
| 2021-02 | 0 | 8.84 |
| 2021-03 | 0 | 11.35 |
| 2021-04 | 0 | 9.62 |
| 2021-05 | 0 | 8.44 |
| 2021-06 | 0 | 8.89 |
| 2021-07 | 0 | 8.17 |
| 2021-08 | 0 | 9.04 |
| 2021-09 | 0 | 8.06 |
| 2021-10 | 0 | 7.2 |
| 2021-11 | 0 | 8.99 |
| 2021-12 | 0 | 9.18 |
| 2022-01 | 0 | 8.58 |
| 2022-02 | 0 | 8.7 |
| 2022-03 | 0 | 9.77 |
| 2022-04 | 0 | 8.77 |
| 2022-05 | 0 | 9.95 |
| 2022-06 | 0 | 7.11 |
| 2022-07 | 0 | 6.6 |
| 2022-08 | 0 | 8.11 |
| 2022-09 | 0 | 8.35 |
| 2022-10 | 0 | 10.33 |
| 2022-11 | 0 | 8.06 |
| 2022-12 | 0 | 8.62 |
| 2023-01 | 0 | 6.79 |
| 2023-02 | 0 | 11.33 |
| 2023-03 | 0 | 13.91 |
| 2023-04 | 0 | 12.87 |
| 2023-05 | 0 | 12.59 |
| 2023-06 | 0 | 10.3 |
| 2023-07 | 0 | 14.46 |
| 2023-08 | 0 | 15.68 |
| 2023-09 | 0 | 15.93 |
| 2023-10 | 0 | 10.54 |
| 2023-11 | 0 | 13.98 |
| 2023-12 | 0 | 13.53 |
| 2024-01 | 0 | 13.31 |
| 2024-02 | 0 | 13.04 |
| 2024-03 | 0 | 14.42 |
| 2024-04 | 0 | 8.95 |
| 2024-05 | 0 | 11.6 |
| 2024-06 | 0 | 10.11 |
| 2024-07 | 0 | 11.77 |
| 2024-08 | 0 | 11.34 |
| 2024-09 | 0 | 13.41 |
| 2024-10 | 0 | 16 |
| 2024-11 | 0 | 12.26 |
| 2024-12 | 0 | 11.03 |
| 2025-01 | 0 | 12.86 |
| 2025-02 | 0 | 10.22 |
| 2025-03 | 0 | 13.62 |
| 2025-04 | 0 | 9.55 |
| 2025-05 | 0 | 10.35 |
| 2025-06 | 0 | 7.89 |
| 2025-07 | 0 | 12 |
| 2025-08 | 0 | 8.33 |
| 2025-09 | 0 | 7.63 |
| 2025-10 | 0 | 11.44 |
| 2025-11 | 0 | 8.83 |
| 2025-12 | 0 | 9.36 |
| 2026-01 | 0 | 9.19 |
| 2026-02 | 0 | 10.78 |
| 2026-03 | 0 | 9.92 |
| 2026-04 | 0 | 14.88 |
| 2026-05 | 0 | 13.28 |
| 2026-06 | 0 | 11.62 |
Regulatory clearances
- K131223 SESE 2013-08-28 (k number procode)
Predicate lineage
K131223 — cites (transitively): K102239 (d1), K061185 (d2), K092027 (d2), K092680 (d2) — cited as predicate by K150298, K191149, K191249
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — GE Healthcare Finland Oy
- VAI 2012-02-02 GE Healthcare Finland Oy · 1 citations