MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Reported: April 20, 2022 Initiated: March 16, 2022 #Z-0919-2022
Product Description
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 147 units
- 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
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008. Recalled by GE Healthcare, LLC. Units affected: 147 units.
Why was this product recalled? ▼
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2022. Severity: Moderate. Recall number: Z-0919-2022.
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