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RecallWatchMedical Device Safety
Class IIOngoingZ-1938-2025

GE Medical Systems Information Technologies Inc recalls MUSE 5 Systems

GE Medical Systems Information Technologies IncMilwaukee, WI, United StatesReported Jun 18, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information
    400 affected lots
    ABF04400266FASAD04390481GASAD05091885GASAD05091907GASAD05091908GAPA2155054PA2155057PA2155059
    +392 morePA2155061PA2155063SAD05302639GASAD05302646GASAD05322687GASAD05322723GASAD05322735GASAD06524784GASAD06204075GASAD06204076GASAD06204077GASAD04380416GASAD04380427GASAD04430607GASAD04440716GASAD04440717GASAD04440718GASAD04440719GASAD05453127GASAD05453128GASAD05453129GASAD05453130GASAD05453172GASAD08105319GASAD08105320GASAD04501236GASAD04501237GASAD04501252GASAD04501257GASAD04501258GASAD04350305GASAD04350317GASAD04350318GASAD04350319GASAD04350320GASAD04350326GASAD06424592GASAD06444630GASAD06454662GASAD04491128GASAD04491129GASAD04491130GASAD04491131GASAD04491132GASAD04491151GASAD04501216GASAD04501217GASAD04501218GASAD04501220GASAD04501221GASAD04501222GASAD04501223GASAD04501224GASAD04501225GASAD04501226GASAD04501227GASAD04501228GASAD04501229GAPA2020935PA2020936SAD05081763GASAD05081836GASAD05091867GASAD05091868GASAD0932SAD09335621GASAD09335622GASAD05302635GASAD06344526GASAD05091896GASAD05091905GASAD05091906GASAD06424610GASAD06444638GASAD06194039GASAD06194040GASAD06194041GASAD05172239GASAD05172240GASAD05172241GASAD05172242GASAD05172243GASAD05172268GASAD05172269GASAD05172271GASAD06204073GASAD05382932GASAD05392967GASAD07455199GASAD08285434GASAD06113777GASAD06113778GASAD06113779GASAD06113780GAPA2297273SAD07205030GASAD07205031GASAD07215068GASAD07215069GASAD05302649GASAD05322725GASAD05332753GASAD05352769GASAD05473247GASAD06023533GASAD06023574GASAD06474699GASAD05513429GASAD05513433GASAD05513435GASAD05513436GASAD05523459GASAD08355476GASAD05021340GASAD05021369GASAD05021370GASAD05021371GASAD05352768GASAD05352770GASAD05352776GASAD05352777GASAD05503390GASAD05503394GASAD05503395GASAD05523447GASAD05523448GASAD05523449GASAD06033597GASAD06033598GASAD06033599GASAD06033600GASAD06033601GASAD04491155GASAD04491156GASAD04491157GASAD06444629GASAD06474693GASAD05061599GASAD04450783GASAD04470920GASAD04470921GASAD04470922GASAD04470923GASAD04430609GASAD04430610GASAD04440662GASAD04440663GASAD04390495GASAD04390496GASAD04390528GASAD04390529GASAD04440723GASAD04440724GASAD04440725GASAD04390482GASAD04390483GASAD04390484GASAD05503399GASAD06204071GASAD06214093GASAD06214094GASAD06214095GASAD04450735GASAD04450736GASAD06454656GASAD06454659GASAD06073742GASAD04511286GASAD04511314GASAD04511315GASAD04511317GASAD06204062GASAD06204063GASAD06234131GASAD06234132GASAD06234133GASAD06234134GASAD06394581GASAD06524786GASAD06524787GASAD06524788GASAD07024812GASAD06113788GASAD04410533GASAD04410534GASAD04410535GASAD04420575GASAD04420577GASAD04420578GAPA2305331SAD06113828GASAD06123870GASAD06123877GASAD06123878GASAD05031412GASAD05031413GASAD05031414GASAD05031415GASAD05031416GASAD05041424GASAD05041425GASAD05041426GASAD05041427GASAD05041428GASAD05041429GASAD05041430GASAD05041431GASAD05041432GASAD05041433GASAD05041434GASAD05041435GASAD05041436GASAD05041437GASAD05041438GASAD05041439GASAD05041440GASAD05041446GASAD05041447GASAD05041448GASAD05041449GASAD05051450GASAD05051451GASAD05051452GASAD05051453GASAD05051454GASAD05051455GASAD05051456GASAD05051457GASAD05051458GASAD05051459GASAD05051460GASAD05051461GASAD05051462GASAD05051463GASAD05051464GASAD05051465GASAD05051466GASAD05051467GASAD05051468GASAD05051469GASAD05051470GASAD05051471GASAD05051472GASAD05051473GASAD05051474GASAD05051475GASAD05392976GASAD05392978GASAD05392979GASAD05392980GASAD05392981GASAD05403010GASAD05403011GASAD05403012GASAD05392977GASAD05292610GASAD05302640GASAD05302641GASAD05182284GASAD05182297GASAD05182299GASAD05182300GASAD05182302GASAD04380402GASAD04380403GASAD04390443GASAD04390444GASAD04390447GASAD04390449GASAD04440671GAPA2020328SAD06143930GASAD06143931GASAD06143932GASAD05111959GASAD05142093GASAD06073699GASAD06073700GASAD06073704GASAD06073705GASAD06073706GASAD06073707GASAD06073702GASAD06073738GASAD06073739GASAD06073740GASAD07084847GASAD05081857GASAD05091880GASAD05091881GASAD04460880GASAD08515553GASBR08522301GASAD04450738GASAD04450739GASAD04450740GASAD05111954GASAD05111961GASAD05051548GASAD05051549GASAD05061554GASAD05061555GASAD05061556GASAD05061557GASAD05061558GASAD05061559GASAD05061560GASAD05061561GASAD05061562GASAD05061563GASAD05061564GASAD05061565GASAD05061566GASAD05061567GASAD05061568GASAD05061569GASAD05061570GASAD05061571GASAD05061572GASAD05061573GASAD05061574GASAD05061575GASAD05061580GASAD05061581GASAD05061582GASAD05061583GASAD05061584GASAD05061585GASAD05061586GASAD05061587GASAD05061588GASAD05061589GASAD05061590GASAD05061591GASAD05061592GASAD05061593GASAD05061594GASAD05061595GASAD05061596GASAD05061597GASAD05061598GASAD05061600GASAD05061601GASAD05061602GASAD05061603GASAD05061604GASAD05061605GASAD06344539GASAD06474694GASAD07215060GASAD07325138GASAD07325135GASAD04330300GASAD04330301GASAD05332754GASAD05352771GASAD05352772GASAD05443097GASAD05443113GASAD05443114GASAD05443115GASAD05443116GASAD05443117GASAD05443118GASAD05443119GASAD05443120GASAD05021324GASAD05021366GASAD05021367GASAD05021368GASAD06524761GASAD06524762GASAD06524763GASAD06524772GASAD06524776GASAD06524777GASAD06524778GASAD06073736GASAD06073744GASAD06093751GASAD06093752GASAD06093763GASAD06093764GASAD06123845GASAD06123846GASAD06123847GASAD06123848GASAD06123849GASAD06123850GASAD06123851GASAD06123852GASAD06123854GA

What the firm is doing

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 4/25/25 was sent to customers. Actions to be taken by Customer/User: MUSE 5 systems have reached their End of Sales/Service Support as of November 1, 2014. Please see attached for the End of Sales/Service Support letter that was previously distributed. GE HealthCare recommends that customers replace or upgrade these systems. If you wish to continue using your MUSE 5 system, you should ensure your IT Department provides ongoing prevention of unauthorized access to the system such as not using a well-known password. If passwords are well-known, please update the credentials according to your organization's password policies or contact GE HealthCare Service or your local Service Representative if necessary. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached Medical Device Notification Acknowledgement Response Form to DCAR.Recall@gehealthcare.com. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

DistributionShow details

Worldwide - US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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