Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

B155M

Model B155M Patient Monitor · Ge Medical Systems Information Technologies, Inc. · DI 00195278490254

BZQMonitor, Breathing Frequency · Class II · 21 CFR 868.2375

CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500

CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) · Class II · 21 CFR 868.1700

CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) · Class II · 21 CFR 868.1620

CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase · Class II · 21 CFR 868.1400

CCLAnalyzer, Gas, Oxygen, Gaseous-Phase · Class II · 21 CFR 868.1720

DPZOximeter, Ear · Class II · 21 CFR 870.2710

DQAOximeter · Class II · 21 CFR 870.2700

DQKComputer, Diagnostic, Programmable · Class II · 21 CFR 870.1425

DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) · Class II · 21 CFR 870.2300

DSIDetector And Alarm, Arrhythmia · Class II · 21 CFR 870.1025

DSJAlarm, Blood-Pressure · Class II · 21 CFR 870.1100

DSKComputer, Blood-Pressure · Class II · 21 CFR 870.1110

DXNSystem, Measurement, Blood-Pressure, Non-Invasive · Class II · 21 CFR 870.1130

FLLContinuous Measurement Thermometer · Class II · 21 CFR 880.2910

GWQFull-Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400

KOIStimulator, Nerve, Peripheral, Electric · Class II · 21 CFR 868.2775

KRBProbe, Thermodilution · Class II · 21 CFR 870.1915

MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.1025

MLDMonitor, St Segment With Alarm · Class II · 21 CFR 870.1025

NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500

NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500

NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500

OLTNon-Normalizing Quantitative Electroencephalograph Software · Class II · 21 CFR 882.1400

OLWIndex-Generating Electroencephalograph Software · Class II · 21 CFR 882.1400

OMCReduced- Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400

ORTBurst 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)

InitiatedRecall #ClassStatusReasonLink basis
2025-09-26Z-0455-2026Class IIOpen, ClassifiedPotential 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.

4913172019-01: 0 reports for this device; peer average 10.66/device2019-02: 0 reports for this device; peer average 8.89/device2019-03: 0 reports for this device; peer average 10.66/device2019-04: 0 reports for this device; peer average 8.08/device2019-05: 0 reports for this device; peer average 8.01/device2019-06: 0 reports for this device; peer average 7.08/device2019-07: 0 reports for this device; peer average 8.92/device2019-08: 0 reports for this device; peer average 7.84/device2019-09: 0 reports for this device; peer average 9.88/device2019-10: 0 reports for this device; peer average 8.66/device2019-11: 0 reports for this device; peer average 9.14/device2019-12: 0 reports for this device; peer average 8.68/device2020-01: 0 reports for this device; peer average 8.33/device2020-02: 0 reports for this device; peer average 8.33/device2020-03: 0 reports for this device; peer average 9.39/device2020-04: 0 reports for this device; peer average 9.23/device2020-05: 0 reports for this device; peer average 6.85/device2020-06: 0 reports for this device; peer average 7.35/device2020-07: 0 reports for this device; peer average 6.96/device2020-08: 0 reports for this device; peer average 8.27/device2020-09: 0 reports for this device; peer average 9.02/device2020-10: 0 reports for this device; peer average 8.31/device2020-11: 0 reports for this device; peer average 14.53/device2020-12: 0 reports for this device; peer average 17.23/device2021-01: 0 reports for this device; peer average 13.41/device2021-02: 0 reports for this device; peer average 9.39/device2021-03: 0 reports for this device; peer average 11.73/device2021-04: 0 reports for this device; peer average 10.4/device2021-05: 0 reports for this device; peer average 8.77/device2021-06: 0 reports for this device; peer average 9.7/device2021-07: 0 reports for this device; peer average 8.81/device2021-08: 0 reports for this device; peer average 9.74/device2021-09: 0 reports for this device; peer average 8.53/device2021-10: 0 reports for this device; peer average 7.8/device2021-11: 0 reports for this device; peer average 9.45/device2021-12: 0 reports for this device; peer average 9.63/device2022-01: 0 reports for this device; peer average 9.13/device2022-02: 0 reports for this device; peer average 9.12/device2022-03: 0 reports for this device; peer average 10.36/device2022-04: 0 reports for this device; peer average 9.42/device2022-05: 0 reports for this device; peer average 10.2/device2022-06: 0 reports for this device; peer average 7.32/device2022-07: 0 reports for this device; peer average 6.79/device2022-08: 0 reports for this device; peer average 8.36/device2022-09: 0 reports for this device; peer average 8.68/device2022-10: 0 reports for this device; peer average 10.71/device2022-11: 0 reports for this device; peer average 8.17/device2022-12: 0 reports for this device; peer average 9.21/device2023-01: 0 reports for this device; peer average 7.2/device2023-02: 0 reports for this device; peer average 11.73/device2023-03: 0 reports for this device; peer average 14.35/device2023-04: 0 reports for this device; peer average 13.38/device2023-05: 0 reports for this device; peer average 13.11/device2023-06: 0 reports for this device; peer average 10.79/device2023-07: 0 reports for this device; peer average 14.99/device2023-08: 0 reports for this device; peer average 16.34/device2023-09: 0 reports for this device; peer average 16.84/device2023-10: 0 reports for this device; peer average 11.41/device2023-11: 0 reports for this device; peer average 14.6/device2023-12: 0 reports for this device; peer average 14.51/device2024-01: 0 reports for this device; peer average 14/device2024-02: 0 reports for this device; peer average 13.75/device2024-03: 0 reports for this device; peer average 14.97/device2024-04: 0 reports for this device; peer average 9.41/device2024-05: 0 reports for this device; peer average 11.76/device2024-06: 0 reports for this device; peer average 10.4/device2024-07: 0 reports for this device; peer average 12.31/device2024-08: 0 reports for this device; peer average 12.29/device2024-09: 0 reports for this device; peer average 14.05/device2024-10: 0 reports for this device; peer average 17.12/device2024-11: 0 reports for this device; peer average 12.87/device2024-12: 0 reports for this device; peer average 11.56/device2025-01: 0 reports for this device; peer average 13.65/device2025-02: 0 reports for this device; peer average 10.84/device2025-03: 0 reports for this device; peer average 14.24/device2025-04: 0 reports for this device; peer average 10.1/device2025-05: 0 reports for this device; peer average 10.88/device2025-06: 0 reports for this device; peer average 8.12/device2025-07: 0 reports for this device; peer average 12.6/device2025-08: 0 reports for this device; peer average 8.86/device2025-09: 0 reports for this device; peer average 8.04/device2025-10: 0 reports for this device; peer average 12.04/device2025-11: 0 reports for this device; peer average 9.12/device2025-12: 0 reports for this device; peer average 9.9/device2026-01: 0 reports for this device; peer average 9.7/device2026-02: 0 reports for this device; peer average 11.23/device2026-03: 0 reports for this device; peer average 10.37/device2026-04: 0 reports for this device; peer average 15.92/device2026-05: 0 reports for this device; peer average 13.65/device2026-06: 0 reports for this device; peer average 12.35/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01010.66
2019-0208.89
2019-03010.66
2019-0408.08
2019-0508.01
2019-0607.08
2019-0708.92
2019-0807.84
2019-0909.88
2019-1008.66
2019-1109.14
2019-1208.68
2020-0108.33
2020-0208.33
2020-0309.39
2020-0409.23
2020-0506.85
2020-0607.35
2020-0706.96
2020-0808.27
2020-0909.02
2020-1008.31
2020-11014.53
2020-12017.23
2021-01013.41
2021-0209.39
2021-03011.73
2021-04010.4
2021-0508.77
2021-0609.7
2021-0708.81
2021-0809.74
2021-0908.53
2021-1007.8
2021-1109.45
2021-1209.63
2022-0109.13
2022-0209.12
2022-03010.36
2022-0409.42
2022-05010.2
2022-0607.32
2022-0706.79
2022-0808.36
2022-0908.68
2022-10010.71
2022-1108.17
2022-1209.21
2023-0107.2
2023-02011.73
2023-03014.35
2023-04013.38
2023-05013.11
2023-06010.79
2023-07014.99
2023-08016.34
2023-09016.84
2023-10011.41
2023-11014.6
2023-12014.51
2024-01014
2024-02013.75
2024-03014.97
2024-0409.41
2024-05011.76
2024-06010.4
2024-07012.31
2024-08012.29
2024-09014.05
2024-10017.12
2024-11012.87
2024-12011.56
2025-01013.65
2025-02010.84
2025-03014.24
2025-04010.1
2025-05010.88
2025-0608.12
2025-07012.6
2025-0808.86
2025-0908.04
2025-10012.04
2025-1109.12
2025-1209.9
2026-0109.7
2026-02011.23
2026-03010.37
2026-04015.92
2026-05013.65
2026-06012.35
This device (reports/month)Average device in BZQ, CBQ, CBR, CBS, CCK, CCL, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXN, FLL, GWQ, KOI, KRB, MHX, MLD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT (reports/device/month)

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