Home / Recalls / GE Healthcare, LLC / Z-0919-2022

Z-0919-2022 Class II Terminated

Recalled by GE Healthcare, LLC — Waukesha, WI

FDA device recall Z-0919-2022 was initiated by GE Healthcare, LLC on Mar 16, 2022 and is designated Class II. Reason for recall: Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client. The recall status is terminated (terminated May 4, 2026). Affected quantity: 147 units.

Recall Details

Product Type
Devices
Report Date
Apr 20, 2022
Initiation Date
Mar 16, 2022
Termination Date
May 4, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
147 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US and Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, England, France, Germany, Ireland, Italy, Korea, Malaysia, Netherlands, Norway, Poland, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Turkey

Code Information

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 Numbers: SSR21486211TA

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0919-2022
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources