🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: March 16, 2022 GE Healthcare Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Healthcare, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0919-2022

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