Positron Emission Tomography and Computed Tomography System — Class II medical device recall Z-0448-2021
Ongoing recall by Shanghai United Imaging Healthcare Co., Ltd., reported 2020-11-18, distributed nationwide. A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP
| Recall number | Z-0448-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, China |
| Recall initiated | 2020-08-05 |
| Classified | 2020-11-12 |
| Reported by FDA | 2020-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 9 |
| UPC / GTIN / UDI-DI | 06971576832026 |
| Serial numbers | 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004 |
| Model numbers | 550 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0448-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.