MUSE Cardiology System edits and diagnosis data lost after test signed
GE Healthcare's MUSE Cardiology Information System may lose test measurement edits and diagnosis statements after signing. The Class II recall affects 147 units in the US and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving potential loss of critical cardiac measurement and diagnosis data. No illnesses or injuries have been reported in the source material. The hazard is data loss in a medical context, which presents a risk of harm to patients if incomplete or corrupted data is used in clinical decision-making.
Plain-English summary
GE Healthcare, LLC is recalling the MUSE Cardiology Information System in four model numbers (3101011-040, 3101010-401, 3101010-009, and 3101010-008). The system is a medical device used for managing and analyzing cardiac test data in clinical settings.
Two scenarios may cause edits to measurements and diagnosis statements to be lost after a test is signed in the MUSE NX web client. This means clinical data entered or modified by healthcare providers may be permanently lost, potentially affecting patient care and medical records accuracy.
A total of 147 units have been identified as affected by this issue. These units were distributed to the United States and 24 other countries including Australia, Canada, France, Germany, the United Kingdom, and other international locations.
GE Healthcare recommends that healthcare facilities using affected MUSE systems contact the company for further guidance. Providers should be aware that test data may be lost after signing and should take appropriate precautions to verify data integrity.
The recalled product
- Product
- MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 147
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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