Reported Dec 28, 2022 · Ongoing
B125M Patient Monitor, REF 6160000-004-XXXXXX
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
B125M Patient MonitorREF 6160000-004-XXXXXX
- Lot codes and dates
96 of 96 products
Products covered by this recall Model / number Barcodes Product as published 6160000-00400840682146715UDI/DI 00840682146715: , Serial Numbers: SR722210034SA, SR722210037SA, SR722210030SA, SR722210040SA, SR722210042SA, SR722210039SA, SR722210041SA, SR722220001SA, SR722210029SA, SR722220004SA, SR722220005SA, SR722210031SA, SR722210032SA, SR722220002SA, SR722210035SA, SR722210038SA, SR722210033SA, SR722210028SA, SR722220003SA, SR722210036SA, SR722180001SA, SR722090020WA, SR722090001WA, SR722090013WA, SR722090010WA, SR722090019WA, SR722090024WA, SR722090006WA, SR722090018WA, SR722090025WA, SR722090012WA, SR722090022WA, SR722090021WA, SR722090008WA, SR722090015WA, SR722090009WA, SR722090011WA, SR722090005WA, SR722090004WA, SR722090023WA, SR722090017WA, SR722090002WA, SR722090016WA, SR722090014WA, SR722090007WA, SR722090003WA, SR722340009SA, SR722260035SA, SR722260034SA, SR722260040SA, SR722260029SA, SR722260038SA, SR722260041SA, SR722260032SA, SR722260042SA, SR722260037SA, SR722260026SA, SR722260025SA, SR722260028SA, SR722260024SA, SR722260030SA, SR722260031SA, SR722260033SA, SR722260039SA, SR722260036SA, SR722260027SA, SR722340010SA, SR722340016SA, SR722340011SA, SR722340013SA, SR722340157SA, SR722340012SA, SR722340017SA, SR722210023SA, SR722210010SA, SR722210011SA, SR722210025SA, SR722210019SA, SR722210012SA, SR722210008SA, SR722210013SA, SR722210018SA, SR722210021SA, SR722210014SA, SR722210016SA, SR722210024SA, SR722210026SA, SR722210017SA, SR722210015SA, SR722210009SA, SR722210020SA, SR722210022SA, SR722210007SA, SR722210027SA, SR722300002SA, SR722330067SA, SR722330068SA, SR722330070SA, SR722330071SA, SR722330066SA, SR722330069SA, SR722170006SA, SR722170004SA, SR722170005SA, SR722170003SA, SR722170007SA, SR722170001SA, SR722170002SA 6160000-004-01033170Serial Numbers: SR722350377WA, SR722350378WA 6160000-004-01034790Serial Numbers: SR722370131WA, SR722370128WA, SR722370129WA, SR722370130WA, SR722370132WA, SR722370133WA, SR722370134WA, SR722370135WA, SR722370136WA, SR722370137WA, SR722370138WA, SR722370139WA, SR722370140WA, SR722370141WA, SR722370127WA, SR722370125WA, SR722370126WA 6160000-004-01036427Serial Numbers: SR722220018WA, SR722220016WA, SR722220017WA 6160000-004-01036518Serial Numbers: SR722330072SA 6160000-004-01036836Serial Numbers: SR722320011WA, SR722320008WA, SR722320009WA, SR722320010WA, SR722320012WA, SR722320013WA 6160000-004-01040730Serial Numbers: SR722350150WA, SR722350148WA, SR722350149WA 6160000-004-01040802Serial Numbers: SR722370342WA, SR722370341WA, SR722370343WA, SR722370344WA, SR722370345WA, SR722370346WA, SR722370347WA, SR722370348WA 6160000-004-01051951Serial Numbers: SR722360282WA, SR722360279WA, SR722360280WA, SR722360281WA, SR722360283WA, SR722360284WA, SR722360285WA 6160000-004-01054042Serial Numbers: SR722350045WA, SR722350042WA, SR722350043WA, SR722350044WA, SR722350046WA, SR722350047WA, SR722350048WA, SR722350049WA, SR722350050WA, SR722350051WA 6160000-004-01054990Serial Numbers: SR722380219SA, SR722380216SA, SR722380217SA, SR722380218SA, SR722380220SA, SR722380221SA, SR722380222SA, SR722380223SA, SR722380224SA, SR722380225SA, SR722380226SA, SR722380227SA, SR722380228SA, SR722380229SA, SR722380230SA 6160000-004-01055026Serial Numbers: SR722320053WA, SR722320052WA 6160000-004-01055524Serial Numbers: SR722320042WA 6160000-004-01058339Serial Numbers: SR722320043WA 6160000-004-01059539Serial Numbers: SR722360176WA 6160000-004-01064964Serial Numbers: SR722320054WA 6160000-004-01069980Serial Numbers: SR722330001SA — SR722330002SA, SR722320108SA, SR722320041SA, SR722320106SA, SR722320107SA, SR722320109SA, SR722330003SA 6160000-004-01073870Serial Numbers: SR722360043SA 6160000-004-01074082Serial Numbers: SR722360302SA, SR722360291SA, SR722360300SA, SR722360301SA, SR722360304SA, SR722360305SA, SR722360306SA, SR722360307SA, SR722360308SA, SR722360309SA, SR722360310SA, SR722370012SA, SR722370014SA, SR722370015SA, SR722370019SA, SR722370016SA, SR722370017SA, SR722370018SA, SR722370020SA, SR722370021SA, SR722370058SA, SR722370022SA, SR722370024SA, SR722370025SA, SR722370026SA, SR722370041SA, SR722370045SA, SR722370056SA, SR722370060SA, SR722370063SA, SR722370064SA, SR722370065SA, SR722370066SA, SR722370067SA, SR722370068SA, SR722370069SA, SR722370075SA, SR722370070SA, SR722370071SA, SR722370074SA, SR722370076SA, SR722370077SA, SR722370078SA, SR722370079SA, SR722370080SA, SR722370081SA, SR722370082SA, SR722370083SA, SR722370084SA, SR722370085SA, SR722370091SA, SR722370095SA, SR722370092SA, SR722370093SA, SR722370094SA, SR722370096SA, SR722370097SA, SR722370098SA, SR722370099SA, SR722370100SA - Amount recalled
- 5962
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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