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

Z-0919-2022 Class II Terminated

Recalled by GE Healthcare, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
April 20, 2022
Initiation Date
March 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

Other recalls by GE Healthcare, LLC

  • Z-1767-2026 Class II — SIGNA Premier systems (February 27, 2026)
  • Z-1475-2026 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: (January 16, 2026)
  • Z-0935-2026 Class II — GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processin (November 3, 2025)
  • Z-1484-2025 Class II — GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; (February 19, 2025)
  • Z-1487-2025 Class II — GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers (February 19, 2025)
  • Z-1485-2025 Class II — GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-0 (February 19, 2025)
  • Z-1483-2025 Class II — GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; (February 19, 2025)
  • Z-1486-2025 Class II — GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 203390 (February 19, 2025)
  • Z-0318-2025 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2 (October 3, 2024)
  • Z-0039-2025 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/C (August 29, 2024)