CLASS II Device recall · Reported 19 Aug 2020 · FDA Enforcement Report
uEXPLORER PET/CT Diagnostic Imaging System recalled
Shanghai United Imaging Healthcare is recalling uEXPLORER PET/CT Diagnostic Imaging System, distributed nationwide in the US. The recall was initiated on 16 Jul 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2799-2020
- FDA event ID
- 85948
- Recalling firm
- Shanghai United Imaging Healthcare, Shanghai, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2020
- FDA classified
- 13 Aug 2020
- Reported
- 19 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Imaging Equipment
Timeline
| 16 Jul 2020 | Recall initiated by company | |
| 13 Aug 2020 | Classified by FDA | +28 days |
| 19 Aug 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution including in the state of Texas.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial No. F00002; GTIN 06971576832040
Where was it sold?
US Nationwide distribution including in the state of Texas.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85948| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | uMI 550 PET/CT Diagnostic Imaging System recalled | Shanghai United Imaging Healthcare | Foreign Material | Nationwide |
More recalls from Shanghai United Imaging Healthcare
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ltd Positron Emission Tomography (PET) and Computed Tomography (CT) recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | 4 states |
| Device | CLASS II | Digital Medical X-ray Imaging System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | uMI 550 System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Other | Nationwide |
| Device | CLASS II | uEXPLORER PET/CT System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Other | Nationwide |
Other Imaging Equipment recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |