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 | A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling |
| Product | Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. |
| Quantity | 3 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain. |
| Initiated | 2020-11-23 |
| Classified | 2020-12-22 |
| Terminated | 2023-08-29 |
| Recall number | Z-0695-2021 |
| 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-0695-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86932/
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