Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| Product | MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008 |
| 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 |
| Initiated | 2022-03-16 |
| Classified | 2022-04-13 |
| Terminated | 2026-05-04 |
| Recall number | Z-0919-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-0919-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89834/
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