MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
FDA Recall Z-0919-2022 · Posted None
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeDQK
Date Initiated2022-03-16
Date Terminated2026-05-04
Product Quantity147 units
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.
Firm Action
GE Healthcare notified its consignees by letter titled URGENT MEDICAL DEVICE CORRECTION on March 16, 2022. The letter explained the two scenarios which would produce the loss of edits and provided recommendations and a workaround. The firm will correct all affected products at no cost to you. The firm will be issuing a software patch. A GE Healthcare representative will contact affected customers to arrange for the correction. If you have any questions or concerns regarding this notification, contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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