Recall Z-0919-2022 ยท DQK Computer, Diagnostic, Programmable
GE Healthcare, LLC
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
| Date | Mar 16, 2022 |
| Status | Terminated |
| Reason | Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client. |
| Root cause | Software Manufacturing/Software Deployment |
| 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152993 | MUSE Cardiology Information System Ge Medical Systems Information Technologies, Inc., Jan 12, 2016 |