Recall record at a glance
| Official record | Z-2522-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Report date | Jul 15, 2020 |
| Recall initiation date | May 8, 2020 |
| Quantity | 5 units |
| Location | Shanghai, China |
Official product description
uCT 760 System, Computed Tomography X-ray System
Why the product was recalled
Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.
Distribution information
Distributed to two customers. Both customers located in Houston, Texas.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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