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Use caution Medical device recall · FDA · Published July 16, 2020

uEXPL: PET/CT Scanner May Cause Image Artifacts Due to Signal Drift

Shanghai United Imaging Healthcare recalls uEXPLORER PET/CT scanners that may cause image artifacts and scanning interruptions due to signal drift. Affected units have serial numbers starting with F00002.

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Contact the company

Recalling firmShanghai United Imaging Healthcare Co., Ltd.No. 2258 Chengbei Rd, Jiading Ind. · Shanghai, China
✎ GovInfoNow plain-language explainer

Shanghai United Imaging Healthcare is recalling uEXPLORER PET/CT scanners that may cause image artifacts and scanning interruptions. This could lead to repeat scans and potential skin abrasions from sharp edges in the scanner's metal components. Read more at govinfonow.com/recall/64699-uexpl-pet-ct-scanner-may-cause-image-artifacts-due-to.

Source Summary by GovInfoNow · govinfonow.com/recall/64699-uexpl-pet-ct-scanner-may-cause-image-artifacts-due-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2799-2020

Cite this page

“uEXPL: PET/CT Scanner May Cause Image Artifacts Due to Signal Drift.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64699-uexpl-pet-ct-scanner-may-cause-image-artifacts-due-to. Based on FDA recall #Z-2799-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2799-2020%22&limit=1).

Shanghai United Imaging Healthcare Co., Ltd. recalled one uEXPLORER PET/CT Diagnostic Imaging System on July 16, 2020, according to the FDA. The device may cause image data problems or sharp edges that could lead to abrasions.

How to tell if you have it

  • uEXPLORER PET/CT Diagnostic Imaging System
  • Serial No. F00002
  • UPC 06971576832040

The hazard

The recall cites potential intermittent issues causing image data problems and artifacts, as well as scout scanning interruptions due to angle signal drift. Additionally, a metal edge overlap of the mylar strip in the gantry may create a sharp edge that can lead to repeat scanning and abrasions.

Context

GovInfoNow's records show Shanghai United Imaging Healthcare Co., Ltd. has 14 other recalls on record since July 30, 2019. Other recent recalls of similar products include Positron Emission Tomography and Computed Tomography System recalls (Aug. 11, 2026), uMI PET/CT Scanners recalls (March 1, 2023), and uMI 550 PET/CT System recalls (May 30, 2022). Other recent recalls of similar products include GE Healthcare Omni Legend PET Scanners (Dec. 24, 2025), Philips Spectral CT 7500 RT Software Issues (Aug. 21, 2026), and Philips Ingenuity CT Scanners (Aug. 7, 2026).

How to tell if you have this one

Check for serial numbers starting with F00002 on the uEXPLORER PET/CT scanners. The product is intended for use by qualified healthcare professionals in medical settings.

  • Brand
    Shanghai United Imaging Healthcare
  • Product
    uEXPLORER PET/CT Diagnostic Imaging System
  • Category
    Medical device
FDA recall event · 2 products

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
    Terminated
  • Distribution
    US Nationwide distribution including in the state of Texas.
Recall numberProduct, codes & lotsQuantity
Z-2799-2020uEXPLORER 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.; Serial No. F00002; GTIN 069715768320401 unit distributed to Texas
Z-2800-2020uMI 550 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.; Serial No.s 200017, 200023, 200024 and 200036.4 units
Based on the official FDA remedy

What to do — step by step

  1. Check Scanner Serial Number

    Look for serial numbers starting with F00002 on the uEXPLORER PET/CT scanner.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution including in the state of Texas.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Jul 16, 202012. FDA classified it Class II: Aug 13, 202023. Published in FDA’s Enforcement Report: Aug 19, 202034. FDA terminated the recall: Jul 7, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What should I do if I have this scanner?

Check the serial number starting with F00002. If you have the affected model, contact the manufacturer for further instructions.

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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-2799-2020 (July 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2799-2020 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA