Food, drugs, devices › GE Medical Systems, LLC
Device recall: B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
FDA enforcement event 91176 is a device recall by GE Medical Systems, LLC of Waukesha, WI, initiated 16 Nov 2022 and classified Class II, with 5 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. GE Medical Systems, LLC has 42 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Medical Systems, LLC, Waukesha, WI.
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."
Distribution
"Worldwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0729-2023 | B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX, | 826 devices | Class II | Ongoing | 28 Dec 2022 |
| Z-0730-2023 | B125P Patient Monitor (with E-module slot option), REF 6160000-002 | 388 units | Class II | Ongoing | 28 Dec 2022 |
| Z-0731-2023 | B105M Patient Monitor, REF 6160000-003 | 3905 units | Class II | Ongoing | 28 Dec 2022 |
| Z-0732-2023 | B125M Patient Monitor, REF 6160000-004-XXXXXX | 5962 | Class II | Ongoing | 28 Dec 2022 |
| Z-0733-2023 | B125M Patient Monitor, REF 6160000-005-XXXXXXX | 3348 units | Class II | Ongoing | 28 Dec 2022 |
Context
Other enforcement events for GE Medical Systems, LLC
All 42 events for GE Medical Systems, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.