Class II — GE Healthcare
| 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 | Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported. |
| Product | GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner. |
| Quantity | 13 (7 US, 6 OUS) |
| Distribution | US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates. |
| Initiated | 2014-12-19 |
| Classified | 2015-01-15 |
| Terminated | 2015-04-29 |
| Recall number | Z-0985-2015 |
| 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 (Z-0985-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70074/
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