Recall Z-0733-2023 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Medical Systems, LLC
B125M Patient Monitor, REF 6160000-005-XXXXXXX
| Date | Dec 19, 2022 (initiated Nov 16, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/16/2022. The notice explained the problem and safety issue and requested the following: "You can determine whether your monitor is impacted by looking at the side of your monitor where the parameter acquisition connectors are located. B1x5P with E-module slot option and all B1x5M patient monitors are impacted (See Figure 1). B1x5P patient monitors without E-module slot option are not impacted (See Figure 2). You can also determine whether your monitor is impacted following the affected product direction |
| Quantity | 3348 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P Ge Medical Systems Information Technologies, Inc., Apr 1, 2022 |