Positron Emission Tomograpy and Computed Tomography System — Class II medical device recall Z-1708-2020
Terminated recall by Shanghai United Imaging Healthcare Co., Ltd., reported 2020-04-22, distributed nationwide. Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisi
| Recall number | Z-1708-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, China |
| Recall initiated | 2019-08-26 |
| Classified | 2020-04-15 |
| Reported by FDA | 2020-04-22 |
| Terminated | 2022-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 06971576832026 |
| Serial numbers | 200017, 200023 |
| Model numbers | 550 |
Product
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is 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
Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.
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-1708-2020. 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.