GE Medical Systems, LLC: B105M Patient Monitor, REF 6160000-003

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: 3905 units Lot/code info: UDI/DI 00840682146708: Model Number 6160000-003, Serial Numbers: SR622160009SA, SR622160008SA, SR622092012WA, SR622092005WA, SR622092028WA, SR622092001WA, SR622092007WA, SR622092027WA, SR622092010WA, SR622092024WA, SR622092022WA, SR622092006WA, SR622092020WA, SR622092030WA, SR622092013WA, SR622092019WA, SR622092009WA, SR622092016WA, SR622092018WA, SR622092023WA, SR622092032WA, SR622092029WA, SR622092033WA, SR622092015WA, SR622092008WA, SR622092031WA, SR622092011WA, SR622092002WA, SR622092026WA, SR622092003WA, SR622092034WA, SR622092014WA, SR622092021WA, SR622092017WA, SR622092004WA, SR622092035WA, SR622092025WA, SR622360008SA, SR622360009SA, SR622360001SA, SR622360010SA, SR622360006SA, SR622360003SA, SR622360004SA, SR622360002SA, SR622360005SA, SR622360007SA; Model Number 6160000-003-01034677, Serial Numbers: SR622322001WA, SR622322002WA, SR622322003WA, SR622322004WA, SR622322005WA, SR622322006WA, SR622322007WA, SR622322008WA, SR622322009WA, SR622322010WA, SR622322011WA, SR622322012WA, SR622322013WA, SR622322014WA, SR622322015WA; Model Number 6160000-003-01036673, Serial Numbers: SR622362004WA, SR622362001WA, SR622362002WA, SR622362003WA, SR622362005WA, SR622362006WA, SR622362007WA; Model Number 6160000-003-01045082, Serial Numbers: SR622360071SA, SR622360068SA, SR622360069SA, SR622360070SA, SR622360072SA, SR622360033SA, SR622360030SA, SR622360031SA, SR622360032SA, SR622360034SA, SR622360035SA, SR622360036SA, SR622360037SA, SR622360038SA, SR622360039SA, SR622360040SA, SR62236

UPC codes

00840682146708

Source

Official record: FDA (Device enforcement) ↗

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