Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published August 11, 2026

CT X-ray System uCT 530 Software Issue May Cause Patient Image Visibility Problems

Shanghai United Imaging Healthcare recalls CT X-ray system uCT 530 with software issue that prevents patient images from being visible on the Patient Administration interface, requiring rescans.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3277-2026Medical deviceShanghai United Imaging Healthcare ›
✎ GovInfoNow plain-language explainer

Shanghai United Imaging Healthcare is recalling 4 CT X-ray systems (uCT 530 models) due to a software problem that can prevent patient images from being visible on the Patient Administration interface, potentially requiring rescans. Read more at govinfonow.com/recall/1449372-shanghai-united-imaging-healthcare-co-ltd-recalls-computed-tomography-x.

Source Summary by GovInfoNow · govinfonow.com/recall/1449372-shanghai-united-imaging-healthcare-co-ltd-recalls-computed-tomography-x · Updated October 14, 2026 · FDA enforcement record: FDA #Z-3277-2026

Cite this page

“CT X-ray System uCT 530 Software Issue May Cause Patient Image Visibility Problems.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449372-shanghai-united-imaging-healthcare-co-ltd-recalls-computed-tomography-x. Based on FDA recall #Z-3277-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3277-2026%22&limit=1).

The FDA announced on 2026-08-11 that Shanghai United Imaging Healthcare Co., Ltd. is recalling its Computed Tomography X-ray System, Model uCT 530 with software due to a software issue that may prevent patient images from being visible. This may result in the need for rescans.

How to tell if you have it

  • Brand: Shanghai United Imaging Healthcare
  • Product: CT X-ray System uCT 530
  • Serial Numbers/Software: 300174/R001.19.5.1839204-Re3300SP1H1_P4, 304006/R001.17.6.1607336-Re3100SP4, 304007/R001.19.4.1810621-Re3300SP1H1_P3, 304008/R001.19.4.1810621-Re3300SP1H1_P3
  • Units affected: 4

The hazard

According to the FDA, the positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study. This prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.

Context

GovInfoNow's records show Shanghai United Imaging Healthcare Co., Ltd. has 14 other recalls on record since 2019-07-30. Other recent recalls of similar products include Shanghai United Imaging Healthcare uMI PET/CT Scanners: Software Issue May Cause Image Reconstruction Failure (2023-03-01), Shanghai United Imaging Healthcare uMI 550 PET/CT System Recall: Wi-Fi Interference May Cause Scan Failures (2022-05-30), and uMI 550 System Recall: PET Scan Workflow Freezes After Cancel (2021-08-02).

How to tell if you have this one

Check for serial numbers: 300174, 304006, 304007, or 304008 with specific software versions listed in the recall notice.

  • Brand
    Shanghai United Imaging Healthcare
  • Category
    Medical device
FDA recall event · 12 products

All 12 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
    US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.
Recall numberProduct, codes & lotsQuantity
Z-3277-2026Computed Tomography X-ray System, Model: uCT 530 with software; UDI-DI: 06971576831012. Serial Numbers/Software: 300174/R001.19.5.1839204-Re3300SP1H1_P4, 304006/R001.17.6.1607336-Re3100SP4, 304007/R001.19.4.1810621-Re3300SP1H1_P3, 304008/R001.19.4.1810621-Re3300SP1H1_P34
Z-3278-2026Computed Tomography X-ray System, Model: uCT 550 with software; UDI-DI: 06971576831036. Serial Numbers/Software: 353021/R001.19.6.1857994-Re3300SP1H1_P5, 353045/R001.19.6.1857994-Re3300SP1H1_P5, 353049/R001.19.6.1857994-Re3300SP1H1_P5, 354001/R001.19.6.1857994-Re3300SP1H1_P5, 354004/R001.19.6.1857994-Re3300SP1H1_P5, 354005/R001.19.6.1857994-Re3300SP1H1_P5, 354007/R001.19.6.1857994-Re3300SP1H1_P5, 354009/R001.19.6.1857994-Re3300SP1H1_P5, 354013/R001.19.6.1857994-Re3300SP1H1_P5, 354015/R001.19.6.1857994-Re3300SP1H1_P5, 354016/R001.19.6.1857994-Re3300SP1H1_P5, 354018/R001.17.6.1607336-Re3100SP4, 354020/R001.17.6.1607336-Re3100SP4, 354021/R001.17.6.1607336-Re3100SP4, 354022/R001.19.4.1810621-Re3300SP1H1_P3, 354023/R001.19.6.1857994-Re3300SP1H1_P5, 354024/R001.19.6.1857994-Re3300SP1H1_P5, 354025/R001.19.6.1857994-Re3300SP1H1_P5, 354026/R001.19.6.1857994-Re3300SP1H1_P5, 354027/R001.19.6.1857994-Re3300SP1H1_P5, 354028/R001.19.6.1857994-Re3300SP1H1_P5, 354029/R001.19.6.1857994-Re3300SP1H1_P5, 354030/R001.19.6.1857994-Re3300SP1H1_P523
Z-3279-2026Computed Tomography X-ray System, Model: uCT 760 with software; UDI-DI: 06971576831043. Serial Number/Software: 600271/R003.8.4.1810621-Re3300SP1H1_P31
Z-3280-2026Computed Tomography X-ray System, Model: uCT 780 with software; UDI-DI: 06971576831050. Serial Number/Software: 684001/R001.17.6.1607336-Re3100SP4, 684002/R001.17.6.1607336-Re3100SP4, 684003/R003.8.4.1810621-Re3300SP1H1_P3, 684004/R003.8.4.1810621-Re3300SP1H1_P3, 684005/R003.8.4.1810621-Re3300SP1H1_P3, 684006/R003.8.4.1810621-Re3300SP1H1_P3, 684007/R003.8.4.1810621-Re3300SP1H1_P3, 684008/R003.8.4.1810621-Re3300SP1H1_P3, 684009/R003.8.4.1810621-Re3300SP1H1_P3, 684010/R003.8.4.1810621-Re3300SP1H1_P3, 684011/R003.8.4.1810621-Re3300SP1H1_P3, 684012/R003.9.0.1776134-Re-3300SP2, 684013/R003.11.0.1897081-Re3310SP1, 684014/R003.11.0.1897081-Re3310SP114
Z-3281-2026Computed Tomography X-ray System, Model: uCT ATLAS with software; UDI-DI: 06971576831104. Serial Number/Software: 863001/R001.17.6.1607336-Re3100SP4, 863002/R001.17.6.1607336-Re3100SP4, 863004/R001.17.6.1607336-Re3100SP4, 863005/R001.17.6.1607336-Re3100SP4, 863007/R001.21.0.1897081-Re3310SP1, 863008/R001.21.0.1897081-Re3310SP1, 869001/R001.22.0.2012850-Re3320, 869002/R001.19.4.1810621-Re3300SP1H1_P3, 869003/R001.21.0.1897081-Re3310SP1, 869004/R001.21.0.1897081-Re3310SP1, 11CT863010/R001.17.6.1607336-Re3100SP411
Z-3282-2026Computed Tomography X-ray System, Model: uCT ATLAS Astound with software; UDI-DI: 06971576831340. Serial Number/Software: 803011/R002.9.0.1897081-Re3310SP1, 803012/R002.4.6.1607336-Re3100SP4, 803013/R002.4.6.1607336-Re3100SP4, 803014/R002.9.0.1897081-Re3310SP1, 803016/R002.4.6.1607336-Re3100SP4, 803017/R002.9.0.1897081-Re3310SP1, 803018/R002.9.0.1897081-Re3310SP1, 803019/R002.4.6.1607336-Re3100SP4, 803020/R002.9.0.1897081-Re3310SP1, 803022/R002.9.0.1897081-Re3310SP1, 803023/R002.9.0.1897081-Re3310SP1, 803024/R002.9.0.1897081-Re3310SP1, 809001/R002.8.1.1840891-Re3310A_P1, 809002/R002.9.0.1897081-Re3310SP1, 809003/R002.8.1.1840891-Re3310A_P1, 809004/R002.4.6.1607336-Re3100SP4, 809005/R002.4.6.1607336-Re3100SP4, 809006/R002.8.1.1840891-Re3310A_P1, 809007/R002.4.7.1671762-Re3100SP4_P1, 809008/R002.4.7.1671762-Re3100SP4_P1, 809009/R002.4.7.1671762-Re3100SP4_P1, 809010/R002.4.7.1671762-Re3100SP4_P1, 809011/R002.4.7.1671762-Re3100SP4_P1, 809012/R002.4.7.1671762-Re3100SP4_P1, 809013/R002.4.7.1671762-Re3100SP4_P1, 809014/R002.7.4.1810621-Re3300SP1H1_P3, 809015/R002.7.4.1810621-Re3300SP1H1_P3, 809016/R002.9.0.1897081-Re3310SP1, 809017/R002.9.0.1897081-Re3310SP1, 809018/R002.7.4.1810621-Re3300SP1H1_P3, 809019/R002.7.4.1810621-Re3300SP1H1_P3, 809020/R002.9.0.1897081-Re3310SP1, 809021/R002.7.4.1810621-Re3300SP1H1_P3, 809022/R002.7.4.1810621-Re3300SP1H1_P3, 809023/R002.7.4.1810621-Re3300SP1H1_P3, 809024/R002.7.4.1810621-Re3300SP1H1_P3, 809025/R002.7.4.1810621-Re3300SP1H1_P3, 809026/R002.7.4.1810621-Re3300SP1H1_P3, 809027/R002.7.4.1810621-Re3300SP1H1_P3, 809028/R002.9.0.1897081-Re3310SP1, 809029/R002.7.4.1810621-Re3300SP1H1_P3, 809030/R002.7.4.1810621-Re3300SP1H1_P3, 809031/R002.7.4.1810621-Re3300SP1H1_P3, 809032/R002.7.4.1810621-Re3300SP1H1_P3, 809033/R002.9.0.1897081-Re3310SP1, 809034/R002.9.0.1897081-Re3310SP1, 809035/R002.9.0.1897081-Re3310SP1, 809036/R002.9.0.1897081-Re3310SP1, 809037/R002.9.0.1897081-Re3310SP1, 809038/R002.9.0.1897081-Re3310SP1, 809039/R002.9.0.1897081-Re3310SP1, 809040/R002.9.0.1897081-Re3310SP1, 809041/R002.9.0.1897081-Re3310SP153
Z-3283-2026Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software; UDI-DI: 06971576832026. Serial Number/Software: 200045/R001.19.0.1812568, 200163/R001.19.3.2011750, 200164/R001.18.0.1683822, 200165/R001.18.0.1683822, 200166/R001.18.0.1683822, 200167/R001.18.0.1683822, 202009/R001.19.3.2011750, 202016/R001.19.0.1812568, 202018/R001.19.0.1812568, 202019/R001.19.0.1812568, 202020/R001.19.1.1929746, 202021/R001.19.1.1929746, 202022/R001.19.1.1929746, 230040/R001.19.3.2011750, 230048/R001.19.0.1812568, 230106/R001.19.0.1812568, 232038/R001.19.0.1812568, 232039/R001.19.0.1812568, 232040/R001.19.0.1812568, 232041/R001.19.0.1812568, 232042/R001.19.0.1812568, 232043/R001.19.0.1812568, 232044/R001.19.0.1812568, 232045/R001.19.0.1812568, 232046/R001.19.0.1812568, 232047/R001.19.0.1812568, 232048/R001.19.1.1929746, 232049/R001.19.1.1929746, 232050/R001.19.1.1929746, 232051/R001.19.1.1929746, 202023/R001.19.1.1929746, 202024/R001.19.1.1929746, 232052/R001.19.1.1929746, 232053/R001.19.1.192974634
Z-3284-2026Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software; UDI-DI: 06971576832170. Serial Number: 11MI410003/R001.19.4.1909524, 11MI410004/R001.19.4.1909524, 11MI410005/R001.19.4.1909524, 20MI410001/R001.19.4.1909524, 20MI410002/R001.19.4.1909524, 20MI410003/R001.21.0.1993334, 20MI410004/R001.19.4.19095247
Z-3285-2026Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software; UDI-DI: 06971576832187. Serial Number: 11MIP00007/R001.17.5.1785268, 11MIP00009/R001.18.2.1967222, 11MIP00010/R001.18.2.19672223
Z-3286-2026Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software; UDI-DI: 06971576832231. Serial Number/Software: 11MI500004/R002.4.0.1872339, 11MI500005/R002.4.0.1872339, 11MI500006/R002.4.0.18723393
Z-3287-2026Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software; UDI-DI: 06971576832255. Serial Number/Software: 11MI510005/R003.2.0.1872339, 20MI510001/R003.2.0.1872339, 20MI510002/R003.2.0.1872339, 20MI510003/R003.2.0.1872339, 20MI510004/R003.2.0.1872339, 20MI510005/R003.2.0.18723396
Z-3288-2026Positron Emission Tomography and Computed Tomography System, Model: uMI 780; UDI-DI: 06971576832033. Serial Number/Software: 300098/R001. 19.0.18125681
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify the software version matches the listed serial numbers and versions in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 28 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Colorado, Florida, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 57 days after the firm started it.

1. Firm started the recall: Aug 11, 202612. FDA classified it Class II: Sep 25, 202623. Published in FDA’s Enforcement Report: Oct 7, 202634. Added to GovInfoNow: Oct 13, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

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

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

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-3277-2026 (August 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3277-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on October 14, 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