NA B105P VSP3.0 Patient MonitorRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

5 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

1. 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-0729-2023 · 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-0455-2026 · Sep 26, 2025 · Open, Classified
  B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-
• Z-0733-2023 · Nov 16, 2022 · Open, Classified
  B125M Patient Monitor, REF 6160000-005-XXXXXXX
• Z-0730-2023 · Nov 16, 2022 · Open, Classified
  B125P Patient Monitor (with E-module slot option), REF 6160000-002
• Z-0732-2023 · Nov 16, 2022 · Open, Classified
  B125M Patient Monitor, REF 6160000-004-XXXXXX
• Z-0731-2023 · Nov 16, 2022 · Open, Classified
  B105M Patient Monitor, REF 6160000-003