B125M Patient Monitor, REF 6160000-004-XXXXXX
Reported: December 28, 2022 Initiated: November 16, 2022 #Z-0732-2023
Product Description
B125M Patient Monitor, REF 6160000-004-XXXXXX
Reason for Recall
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.
Details
- Recalling Firm
- GE Medical Systems, LLC
- Units Affected
- 5962
- Distribution
- Worldwide distribution.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
B125M Patient Monitor, REF 6160000-004-XXXXXX. Recalled by GE Medical Systems, LLC. Units affected: 5962.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2022. Severity: Moderate. Recall number: Z-0732-2023.
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