NA B125 VSP3.0 Patient MonitorRecalls & reported problems
GE Medical Systems Information Technologies, Inc. · B125M ATO MODEL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 2 still open.
4 other recalls cover devices cleared under the same FDA submission (K213490); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Sep 26, 2025Class IIOpen, 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.
Z-0455-2026 · Root cause: Component change control · Recall details · FDA record ↗
- Nov 16, 2022Class IIOpen, Classified
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
Z-0732-2023 · Root cause: Device Design · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K213490. One submission often covers many models, so check the product and lot details in each record.
- Z-0733-2023 · Nov 16, 2022 · Open, ClassifiedB125M Patient Monitor, REF 6160000-005-XXXXXXX
- Z-0731-2023 · Nov 16, 2022 · Open, ClassifiedB105M Patient Monitor, REF 6160000-003
- Z-0729-2023 · Nov 16, 2022 · Open, ClassifiedB105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
- Z-0730-2023 · Nov 16, 2022 · Open, ClassifiedB125P Patient Monitor (with E-module slot option), REF 6160000-002
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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