FDA Device recall Z-2705-2020
Computed Tomography X-ray System
- FDA Device
- Class II
- ongoing
- Published 2020-08-05
On 2020-08-05 the FDA classified a Class II recall of Computed Tomography X-ray System by Shanghai United Imaging Healthcare, citing the metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2705-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-06-20 |
| Published | 2020-08-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Shanghai United Imaging Healthcare |
| Distribution | US |
Product
Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
Reason
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Identifiers
| code_info | SN 353020, 353021, 353023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2705-2020%22
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