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

Is my product affected?

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

• UPC 00840682142809

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare is recalling 147 units of its MUSE Cardiology Information System across multiple model numbers (3101011-040, 3101010-401, 3101010-009, and 3101010-008). The systems were distributed in the United States and 23 other countries. The recall was initiated because two specific scenarios can cause edits to measurements and diagnosis statements to be lost after a test is signed in the MUSE NX web client, potentially compromising cardiac test data.

The recall record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: 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 Quantity: 147 units Lot/code info: 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, SSR2

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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