uEXPL: PET/CT System Recall - Workflow Freezes After PET Scan Cancel
Shanghai United Imaging Healthcare recalls uEXPLORER PET/CT systems due to occasional workflow freezes after canceling PET scans. Affected units may require professional evaluation.
Lower-risk recall
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Contact the company
What happened, in plain English
Shanghai United Imaging Healthcare is recalling uEXPLORER PET/CT systems that occasionally freeze after canceling a PET scan. This could disrupt medical imaging procedures and requires professional evaluation. Read more at govinfonow.com/recall/62095-uexpl-pet-ct-system-recall-workflow-freezes-after-pet-scan.
Source Summary by GovInfoNow · govinfonow.com/recall/62095-uexpl-pet-ct-system-recall-workflow-freezes-after-pet-scan · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2594-2021
Cite this page
“uEXPL: PET/CT System Recall - Workflow Freezes After PET Scan Cancel.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62095-uexpl-pet-ct-system-recall-workflow-freezes-after-pet-scan. Based on FDA recall #Z-2594-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2594-2021%22&limit=1).
Why it’s dangerous
The system may freeze during the exam acquisition workflow after canceling a PET scan. This could cause delays in medical imaging procedures but does not pose a direct safety risk to patients or staff.
Who’s affected
Healthcare facilities using the uEXPLORER PET/CT system for medical imaging are likely affected. Medical professionals using the system are at risk of procedure interruptions.
How to tell if you have this one
Check for the model number 88000025 on the system. The system was sold with GTIN/UDI code 06971576832040 and serial number F00002.
- Brand
Shanghai United Imaging Healthcare- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2593-2021 | uMI 550 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.; Model: 88000057 GTIN/UDI Codes: 06971576832026 / 01 06971576832026 240 88000057 21 200017 06971576832026 / 01 06971576832026 240 88000057 21 200023 06971576832026 / 01 06971576832026 240 88000057 21 200024 06971576832026 / 01 06971576832026 240 88000057 21 200036 06971576832026 / 01 06971576832026 240 88000057 21 200045 06971576832026 / 01 06971576832026 240 88000057 21 200047 06971576832057 / 01 06971576832057 240 88000057 21 230002 06971576832057 / 01 06971576832057 240 88000057 21 230003 06971576832057 / 01 06971576832057 240 88000057 21 230004 06971576832057 / 01 06971576832057 240 88000057 21 200059 06971576832057 / 01 06971576832057 240 88000057 21 230005 06971576832057 / 01 06971576832057 240 88000057 21 230006 06971576832057 / 01 06971576832057 240 88000057 21 230007 06971576832057 / 01 06971576832057 240 88000057 21 230008 06971576832057 / 01 06971576832057 240 88000057 21 230009 06971576832057 / 01 06971576832057 240 88000057 21 230010 06971576832057 / 01 06971576832057 240 88000057 21 230011 06971576832057 / 01 06971576832057 240 88000057 21 230012 06971576832057 / 01 06971576832057 240 88000057 21 230013 06971576832057 / 01 06971576832057 240 88000057 21 230014 06971576832057 / 01 06971576832057 240 88000057 21 230015 06971576832057 / 01 06971576832057 240 88000057 21 230016 06971576832057 / 01 06971576832057 240 88000057 21 230017 Serial Numbers: 200017; 200023; 200024; 200036; 200045; 200047; 230002; 230003; 230004; 200059; 230005; 230006; 230007; 230008; 230009; 230010; 230011; 230012; 230013; 230014; 230015; 230016; 230017; | 23 systems |
| Z-2594-2021 | 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.; Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002 | 1 system |
What to do — step by step
Contact Manufacturer
Reach out to Shanghai United Imaging Healthcare for professional evaluation of the system.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Illinois, Indiana, Texas, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2594-2021 (August 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2594-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.