Reported Apr 20, 2022 · Terminated

MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008

GE Healthcare, 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 Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

  • MUSE Cardiology Information System
  • Model Numbers
    • a) 3101011-040
    • b) 3101010-401
    • c) 3101010-009
    • d) 3101010-008
Lot codes and dates
    • a) 3101011-040
    • UDI (01)00840682142809(10)MUSENXSP2
  • Serial Numbers
    • SSR20435644TA
    • SSR20085352TA
    • SSR19455267TA
    • SSR20245386TA
    • SSR20225354TA
    • SSR20235322TA
    • SSR19485286TA
    • SSR20265441TA
    • SSR20435653TA
    • SSR20235349TA
    • SSR20315513TA
    • SSR20045337TA
    • SSR19415230TA
    • SSR19425238TA
    • UDI (01)00840682142809(10)MUSENXSP3
  • Serial Numbers
    • SSR19305164TA
    • SSR21255865TA
    • SSR20525351TA
    • SSR20525347TA
    • SSR20325524TA
    • SSR21326015TA
    • SSR21025368TA
    • SSR21065487TA
    • SSR19395224TA
    • UDI (01)00840682142809(10)MUSENXSP4
  • Serial Numbers
    • SSR19445252TA
    • SSR21035400TA
    • SSR21536318TA
    • SSR22056438TA
    • SSR20225343TA
    • SSR20515315TA
    • SSR20265429TA
    • SSR20465706TA
    • SSR20315501TA b) 3101010-401
    • UDI (01)00840682142809(10)MUSENXSP2
  • Serial Numbers
    • SSR19305178TA
    • SSR19265115TA
    • SSR20315505TA
    • SSR20405600TA
    • SSR20415608TA
    • SSR20255413TA
    • SSR20385590TA
    • SSR20265439TA
    • SSR19485282TA
    • SSR19435251TA
    • SSR20235360TA
    • SSR20125313TA
    • SSR20325529TA
    • SSR20125350TA
    • SSR19445257TA
    • SSR20035336TA
    • SSR19515306TA
    • SSR19415228TA
    • SSR20235369TA
    • SSR20355576TA
    • SSR20515344TA
    • SSR20225349TA
    • SSR20415610TA
    • SSR20335533TA
    • SSR20235365TA
    • SSR20425623TA
    • SSR19525317TA
    • SSR20235346TA
    • UDI (01)00840682142809(10)MUSENXSP3
  • Serial Numbers
    • SSR21185714TA
    • SSR19285150TA
    • SSR21085519TA
    • SSR21356058TA
    • SSR20455682TA
    • SSR21215784TA
    • SSR21275895TA
    • SSR21285908TA
    • SSR21205767TA
    • SSR20295480TA
    • SSR21045424TA
    • SSR21175691TA
    • SSR21055448TA
    • SSR19355213TA
    • SSR21065475TA
    • SSR21055459TA
    • SSR21165669TA
    • SSR21185705TA
    • SSR21195741TA
    • SSR21125596TA
    • SSR21235844TA
    • SSR20465707TA
    • SSR21315999TA
    • SSR21426117TA
    • SSR21155657TA
    • SSR21426114TA
    • SSR21035404TA
    • SSR21295941TA
    • SSR20235345TA
    • SSR21055456TA
    • SSR20315499TA
    • SSR20315500TA
    • SSR20275464TA
    • SSR21185719TA
    • SSR21185720TA
    • SSR21386052TA
    • SSR21386053TA
    • SSR21386054TA
    • SSR21436118TA
    • SSR21436122TA
    • SSR21436123TA
    • SSR20235325TA
    • SSR21185731TA
    • SSR20315494TA
    • SSR20315493TA
    • SSR20265446TA
    • SSR21356057TA
    • UDI (01)00840682142809(10)MUSENXSP4
  • Serial Numbers
    • SSR21476197TA
    • SSR21305971TA
    • SSR21506267TA
    • SSR21185730TA
    • SSR21396072TA
    • SSR21486216TA
    • SSR21476205TA
    • SSR21356047TA
    • SSR21215780TA
    • SSR21506263TA
    • SSR21225815TA
    • SSR21496242TA
    • SSR21526307TA
    • SSR19505289TA
    • SSR21516287TA
    • SSR22046398TA
    • SSR21516281TA
    • SSR21526299TA
    • SSR21416095TA
    • SSR21235846TA
    • SSR21336022TA
    • SSR20295484TA
    • SSR21275889TA
    • SSR21496247TA
    • SSR22096508TA
    • SSR21506252TA
    • SSR21466153TA
    • SSR22066453TA
    • c) 3101010-009
    • UDI (01)00840682142809(10)MUSENXSP3
  • Serial Numbers
    • SSR21095569TA
    • SSR21135614TA
    • SSR21025386TA
    • UDI (01)00840682142809(10)MUSENXSP4
  • Serial Numbers
    • SSR22026369TA
    • SSR22046388TA
    • d) 3101010-008
    • UDI (01)00840682142809(10)MUSENXSP2
  • Serial Numbers
    • SSR20235354TA
    • SSR20505775TA
    • SSR20255408TA
    • UDI (01)00840682142809(10)MUSENXSP3
  • Serial Numbers
    • SSR21366065TA
    • SSR21065468TA
    • SSR21316007TA
    • UDI (01)00840682142809(10)MUSENXSP4
  • Serial NumbersSSR21486211TA
Amount recalled
147 units

Why it was recalled

Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 4, 2026 · Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.