FDA Device recall Z-2799-2020
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to…
- FDA Device
- Class II
- terminated
- Published 2020-08-19
On 2020-08-19 the FDA classified a Class II recall of uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to… by Shanghai United Imaging Healthcare, citing 1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2799-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-16 |
| Published | 2020-08-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Shanghai United Imaging Healthcare |
| Distribution | US |
Product
uEXPLORER PET/CT Diagnostic Imaging System - 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
1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions.
Identifiers
| code_info | Serial No. F00002; GTIN 06971576832040 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2799-2020%22
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