Drug recall
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed…
FDA recall event 85771 · Class II · Shanghai United Imaging Healthcare Co., Ltd.
Key facts
| Event ID | 85771 |
|---|---|
| Recall numbers | Z-2641-2020 |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Product type | Devices |
| Products | Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent… |
| Initiation date | May 23, 2020 |
| Report date | Jul 29, 2020 |
| City | Shanghai |
| Country | China |
| FEI number | 3011015597 |
At a glance
- 1–9 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: