B155M
Model B155M Patient Monitor · Ge Medical Systems Information Technologies, Inc. · DI 00195278490254
BZQ — Monitor, Breathing Frequency · Class II · 21 CFR 868.2375
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
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
DXN — System, Measurement, Blood-Pressure, Non-Invasive · Class II · 21 CFR 870.1130
FLL — Continuous Measurement Thermometer · Class II · 21 CFR 880.2910
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
NHQ — Analyzer, Gas, Isoflurane, 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 (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2025-09-26 | Z-0455-2026 | Class II | Open, Classified | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment. | code info di |
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 | 10.66 |
| 2019-02 | 0 | 8.89 |
| 2019-03 | 0 | 10.66 |
| 2019-04 | 0 | 8.08 |
| 2019-05 | 0 | 8.01 |
| 2019-06 | 0 | 7.08 |
| 2019-07 | 0 | 8.92 |
| 2019-08 | 0 | 7.84 |
| 2019-09 | 0 | 9.88 |
| 2019-10 | 0 | 8.66 |
| 2019-11 | 0 | 9.14 |
| 2019-12 | 0 | 8.68 |
| 2020-01 | 0 | 8.33 |
| 2020-02 | 0 | 8.33 |
| 2020-03 | 0 | 9.39 |
| 2020-04 | 0 | 9.23 |
| 2020-05 | 0 | 6.85 |
| 2020-06 | 0 | 7.35 |
| 2020-07 | 0 | 6.96 |
| 2020-08 | 0 | 8.27 |
| 2020-09 | 0 | 9.02 |
| 2020-10 | 0 | 8.31 |
| 2020-11 | 0 | 14.53 |
| 2020-12 | 0 | 17.23 |
| 2021-01 | 0 | 13.41 |
| 2021-02 | 0 | 9.39 |
| 2021-03 | 0 | 11.73 |
| 2021-04 | 0 | 10.4 |
| 2021-05 | 0 | 8.77 |
| 2021-06 | 0 | 9.7 |
| 2021-07 | 0 | 8.81 |
| 2021-08 | 0 | 9.74 |
| 2021-09 | 0 | 8.53 |
| 2021-10 | 0 | 7.8 |
| 2021-11 | 0 | 9.45 |
| 2021-12 | 0 | 9.63 |
| 2022-01 | 0 | 9.13 |
| 2022-02 | 0 | 9.12 |
| 2022-03 | 0 | 10.36 |
| 2022-04 | 0 | 9.42 |
| 2022-05 | 0 | 10.2 |
| 2022-06 | 0 | 7.32 |
| 2022-07 | 0 | 6.79 |
| 2022-08 | 0 | 8.36 |
| 2022-09 | 0 | 8.68 |
| 2022-10 | 0 | 10.71 |
| 2022-11 | 0 | 8.17 |
| 2022-12 | 0 | 9.21 |
| 2023-01 | 0 | 7.2 |
| 2023-02 | 0 | 11.73 |
| 2023-03 | 0 | 14.35 |
| 2023-04 | 0 | 13.38 |
| 2023-05 | 0 | 13.11 |
| 2023-06 | 0 | 10.79 |
| 2023-07 | 0 | 14.99 |
| 2023-08 | 0 | 16.34 |
| 2023-09 | 0 | 16.84 |
| 2023-10 | 0 | 11.41 |
| 2023-11 | 0 | 14.6 |
| 2023-12 | 0 | 14.51 |
| 2024-01 | 0 | 14 |
| 2024-02 | 0 | 13.75 |
| 2024-03 | 0 | 14.97 |
| 2024-04 | 0 | 9.41 |
| 2024-05 | 0 | 11.76 |
| 2024-06 | 0 | 10.4 |
| 2024-07 | 0 | 12.31 |
| 2024-08 | 0 | 12.29 |
| 2024-09 | 0 | 14.05 |
| 2024-10 | 0 | 17.12 |
| 2024-11 | 0 | 12.87 |
| 2024-12 | 0 | 11.56 |
| 2025-01 | 0 | 13.65 |
| 2025-02 | 0 | 10.84 |
| 2025-03 | 0 | 14.24 |
| 2025-04 | 0 | 10.1 |
| 2025-05 | 0 | 10.88 |
| 2025-06 | 0 | 8.12 |
| 2025-07 | 0 | 12.6 |
| 2025-08 | 0 | 8.86 |
| 2025-09 | 0 | 8.04 |
| 2025-10 | 0 | 12.04 |
| 2025-11 | 0 | 9.12 |
| 2025-12 | 0 | 9.9 |
| 2026-01 | 0 | 9.7 |
| 2026-02 | 0 | 11.23 |
| 2026-03 | 0 | 10.37 |
| 2026-04 | 0 | 15.92 |
| 2026-05 | 0 | 13.65 |
| 2026-06 | 0 | 12.35 |
Regulatory clearances
- K253277 SESE 2026-07-24 (k number procode)
Manufacturer compliance record — Ge Medical Systems Information Technologies, Inc.
- VAI 2018-07-19 GE Medical Systems Information Technologies, Inc. · 5 citations
- NAI 2016-04-28 GE Medical Systems Information Technologies · 0 citations
- VAI 2013-09-25 GE Medical Systems Information Technologies, Inc. · 5 citations
- VAI 2013-05-14 GE Medical Systems Information Technologies · 0 citations
- VAI 2012-10-09 GE Medical Systems Information Technologies, Inc. · 6 citations
- NAI 2010-08-20 GE Medical Systems Information Technologies, Inc. · 0 citations