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GE Healthcare, LLC recalls MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Recalled April 20, 2022 · FDA recall Z-0919-2022 · GE Healthcare
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. · FDA Class II
Units
147 units
Sold at
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
Description
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
Product
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →