Recall Z-0733-2023— GE Medical Systems, LLC

Name: FDA recall Z-0733-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-16

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2022-11-16. It names one FDA 510(k) clearance: K213490. Product: B125M Patient Monitor, REF 6160000-005-XXXXXXX. Reason: 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..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-11-16
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K213490 — Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.·cleared 2022-04-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

B125M Patient Monitor, REF 6160000-005-XXXXXXX

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.