FDA-Device2022-04-20Class II
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
GE Healthcare, LLC
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.
Sold states
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
Affected count
147 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0919-2022Don't want to check this manually?
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