GE Medical Systems, LLC: B125M Patient Monitor, REF 6160000-005-XXXXXXX

Hazard

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 from the source

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. Quantity: 3348 units Lot/code info: UDI/DI 00840682146791: Model Number 6160000-005, Serial Numbers: SR821512013WA, SR821512014WA, SR821512017WA, SR821512016WA, SR821512015WA, SR821430047WA, SR821430049WA, SR821430048WA, SR821430050WA, SR821410068WA, SR821170021WA, SR822062011WA, SR821260059WA, SR822072018WA, SR822072016WA, SR822072015WA, SR822072022WA, SR822072021WA, SR822072020WA, SR822072019WA, SR822072017WA, SR822072014WA, SR822072013WA, SR821170023WA, SR821180036WA, SR821180037WA, SR821180035WA, SR821180038WA, SR821180039WA, SR821210003WA, SR821210001WA, SR821210002WA, SR821210004WA, SR821210005WA, SR821210006WA, SR821210007WA, SR821210008WA, SR821210009WA, SR821210010WA, SR821250021WA, SR821250027WA, SR821250022WA, SR821250023WA, SR821250024WA, SR821250025WA, SR821260010WA, SR822072012WA, SR822072011WA, SR822072003WA, SR822072005WA, SR822072010WA, SR822072006WA, SR822072009WA, SR822072008WA, SR822072007WA, SR822072004WA, SR821260012WA, SR822062004WA, SR822062005WA, SR822062006WA, SR822290015SA, SR822300010SA, SR822300002SA, SR822300005SA, SR822300007SA, SR822300008SA, SR822300004SA, SR822290019SA, SR822300006SA, SR822290012SA, SR822300001SA, SR822300009SA, SR822290017SA, SR822290018SA, SR822300003SA, SR821170005WA, SR821170020WA, SR821170017WA, SR821170018WA, SR821170019WA, SR821170006WA, SR821410025WA, SR821410001WA, SR821410023WA, SR821410024WA, SR822062010WA, SR821170030WA, SR821170029WA, SR821260056WA, SR821260066WA, SR821260065WA, SR821260064WA, SR821260060WA, SR821260058WA, SR821170033WA, SR82117003

UPC codes

00840682146791

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.