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 | Ongoing |
| Reason | There is potential for the images to be flipped left to right. |
| Product | SIGNA Excite 3T. Magnetic Resonance Imaging System |
| Quantity | 55 units |
| Distribution | Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, S… |
| Initiated | 2022-02-18 |
| Classified | 2022-04-04 |
| Recall number | Z-0859-2022 |
| 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-0859-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89720/
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