FDA Device recall Z-2594-2021
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localiza…
- FDA Device
- Class II
- ongoing
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localiza… by Shanghai United Imaging Healthcare, citing the EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2594-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-02 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Shanghai United Imaging Healthcare |
| Distribution | US |
Product
uEXPLORER PET/CT System - 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
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Identifiers
| code_info | Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2594-2021%22
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