Reported Dec 28, 2022 · Ongoing
B105M Patient Monitor, REF 6160000-003
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?
B105M Patient MonitorREF 6160000-003
- Lot codes and dates
60 of 60 products
Products covered by this recall Model / number Barcodes Product as published 6160000-00300840682146708UDI/DI 00840682146708: , 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 6160000-003-01034677Serial Numbers: SR622322001WA, SR622322002WA, SR622322003WA, SR622322004WA, SR622322005WA, SR622322006WA, SR622322007WA, SR622322008WA, SR622322009WA, SR622322010WA, SR622322011WA, SR622322012WA, SR622322013WA, SR622322014WA, SR622322015WA 6160000-003-01036673Serial Numbers: SR622362004WA, SR622362001WA, SR622362002WA, SR622362003WA, SR622362005WA, SR622362006WA, SR622362007WA 6160000-003-01045082Serial Numbers: SR622360071SA, SR622360068SA, SR622360069SA, SR622360070SA, SR622360072SA, SR622360033SA, SR622360030SA, SR622360031SA, SR622360032SA, SR622360034SA, SR622360035SA, SR622360036SA, SR622360037SA, SR622360038SA, SR622360039SA, SR622360040SA, SR622360041SA, SR622360042SA, SR622360043SA, SR622360044SA, SR622360045SA, SR622360046SA, SR622360047SA, SR622360048SA, SR622360049SA, SR622360050SA, SR622360051SA, SR622360052SA, SR622360053SA, SR622360054SA, SR622360058SA, SR622360059SA, SR622360060SA, SR622360061SA, SR622360062SA, SR622360063SA, SR622360064SA, SR622360065SA, SR622360067SA, SR622360066SA 6160000-003-01047272Serial Numbers: SR622362012WA, SR622362009WA, SR622362010WA, SR622362011WA, SR622362013WA 6160000-003-01054632Serial Numbers: SR622322041WA, SR622322040WA 6160000-003-01054644Serial Numbers: SR622362019WA, SR622362022WA 6160000-003-01054806Serial Numbers: SR622362020WA, SR622362021WA 6160000-003-01056201Serial Numbers: SR622372110WA, SR622372111WA, SR622372112WA 6160000-003-01058032Serial Numbers: SR622362008WA 6160000-003-01058330Serial Numbers: SR622322032WA, SR622322033WA, SR622322034WA, SR622322035WA 6160000-003-01059142Serial Numbers: SR622362075WA 6160000-003-01060133Serial Numbers: SR622372087WA, SR622372088WA, SR622372089WA, SR622372090WA, SR622372091WA, SR622372092WA 6160000-003-01062599Serial Numbers: SR622372027WA 6160000-003-01079753Serial Numbers: SR622360025SA, SR622360022SA, SR622360023SA, SR622360024SA, SR622360026SA, SR622360027SA, SR622360014SA, SR622360011SA, SR622360012SA, SR622360013SA, SR622360015SA, SR622360016SA, SR622360017SA, SR622360018SA, SR622360019SA, SR622360020SA, SR622360021SA 6160000-003-01086095Serial Numbers: SR622370001SA 6160000-003-100174Serial Numbers: SR622152004WA, SR622152001WA, SR622152002WA, SR622152003WA, SR622152005WA, SR622152006WA, SR622152007WA, SR622152008WA, SR622152009WA, SR622152010WA, SR622152011WA, SR622152012WA, SR622152013WA, SR622152014WA, SR622152015WA, SR622152020WA, SR622152016WA, SR622152017WA, SR622152018WA, SR622152019WA 6160000-003-100318Serial Numbers: SR622192037WA, SR622192036WA 6160000-003-100392Serial Numbers: SR622192031WA 6160000-003-100536Serial Numbers: SR622192002WA, SR622192001WA - Amount recalled
- 3905 units
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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