Drug recall
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
FDA recall event 95704 · Class II · GE Healthcare (China) Co., Ltd.
Key facts
| Event ID | 95704 |
|---|---|
| Recall numbers | Z-0600-2025, Z-0601-2025, Z-0602-2025, Z-0603-2025, Z-0604-2025, Z-0605-2025, Z-0606-2025, Z-0607-2025, Z-0608-2025, Z-0609-2025, Z-0610-2025, Z-0611-2025 and 5 more |
| Recalling firm | GE Healthcare (China) Co., Ltd. |
| Product type | Devices |
| Products | GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:, GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system, GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed Elite…, GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT, GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD and 12 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly… |
| Initiation date | Nov 5, 2024 |
| Report date | Dec 11, 2024 |
| City | Beijing |
| Country | China |
| FEI number | 3008284470 |
At a glance
- 10–99 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: