B125M · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

1 linked reportInjury 1

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	10.76
2019-02	0	8.93
2019-03	0	10.3
2019-04	0	8.66
2019-05	0	8.43
2019-06	0	6.86
2019-07	0	8.74
2019-08	0	7.86
2019-09	0	10.3
2019-10	0	9.09
2019-11	0	9.38
2019-12	0	9.21
2020-01	0	8.24
2020-02	0	7.84
2020-03	0	9.65
2020-04	0	9.29
2020-05	0	6.78
2020-06	0	7.24
2020-07	0	6.93
2020-08	0	8.06
2020-09	0	9.21
2020-10	0	7.94
2020-11	0	14.53
2020-12	0	17.77
2021-01	0	13.78
2021-02	0	9.22
2021-03	0	11.6
2021-04	0	10.79
2021-05	0	8.74
2021-06	0	9.99
2021-07	0	8.82
2021-08	0	9.87
2021-09	0	8.46
2021-10	0	7.85
2021-11	0	9.38
2021-12	0	9.51
2022-01	0	9.15
2022-02	0	9.11
2022-03	0	10.29
2022-04	0	9.29
2022-05	0	9.92
2022-06	0	7.33
2022-07	0	6.64
2022-08	0	8.28
2022-09	0	8.49
2022-10	0	10.85
2022-11	0	8.08
2022-12	0	9.21
2023-01	0	7.28
2023-02	0	11.82
2023-03	0	14.11
2023-04	0	13.8
2023-05	0	13.24
2023-06	0	10.94
2023-07	0	14.92
2023-08	0	16.11
2023-09	0	16.54
2023-10	0	11.52
2023-11	0	14.77
2023-12	0	14.67
2024-01	0	14.42
2024-02	0	14
2024-03	0	15.1
2024-04	0	9.19
2024-05	0	11.91
2024-06	0	10.37
2024-07	0	12.36
2024-08	0	12.52
2024-09	0	14.43
2024-10	0	17.18
2024-11	0	13.2
2024-12	0	11.89
2025-01	0	13.73
2025-02	0	10.94
2025-03	0	14.09
2025-04	0	10.02
2025-05	0	11.05
2025-06	0	8.22
2025-07	0	12.71
2025-08	0	9.05
2025-09	0	8.28
2025-10	1	12.04
2025-11	0	9.23
2025-12	0	10.03
2026-01	0	9.8
2026-02	0	11.31
2026-03	0	10.6
2026-04	0	16.33
2026-05	0	13.52
2026-06	0	12.54

This device (reports/month)Average device in BZQ, CBQ, CBR, CBS, CCK, CCL, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXN, FLL, GWO, KOI, KRB, MHX, MLD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT (reports/device/month)

Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	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.Distribution: Worldwide - US Nationwide distribution.	7408	code info di

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-10-30	9710602-2025-03671	Injury	Available	exact di

Regulatory clearances

510(k)K253277Substantially equivalent (SESE) · 2026-07-24clearance family

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2018-07-19	VAI	Voluntary action indicated	GE Medical Systems Information Technologies, Inc.	5
2016-04-28	NAI	No action indicated	GE Medical Systems Information Technologies	0
2013-09-25	VAI	Voluntary action indicated	GE Medical Systems Information Technologies, Inc.	5
2013-05-14	VAI	Voluntary action indicated	GE Medical Systems Information Technologies	0
2012-10-09	VAI	Voluntary action indicated	GE Medical Systems Information Technologies, Inc.	6
2010-08-20	NAI	No action indicated	GE Medical Systems Information Technologies, Inc.	0

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