FDA Device recall Z-0448-2021
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be op…
- FDA Device
- Class II
- ongoing
- Published 2020-11-18
On 2020-11-18 the FDA classified a Class II recall of Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be op… by Shanghai United Imaging Healthcare, citing A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0448-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-08-05 |
| Published | 2020-11-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Shanghai United Imaging Healthcare |
| Distribution | US |
Product
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Reason
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Identifiers
| code_info | Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004 |
|---|
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-0448-2021%22
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