Lower risk Medical device recall · FDA · Published June 20, 2020

Shanghai United Imaging Healthcare uCT 530 CT Scanner Recall: Uneven Metal Edge Risk

Shanghai United Imaging Healthcare recalls uCT 530 CT scanners with uneven metal edges that could cause sharp injuries. Affected units have specific serial numbers and were sold with certain GTINs. Contact for repair or replacement.

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

🇺🇸 FDA recall #Z-2704-2020Medical device Shanghai United Imaging Healthcare ›

Lower-risk recall

The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

Take action

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 uCT 530 CT scanners due to uneven metal edges that could create sharp edges. This poses a risk of injury if the scanner is handled improperly. Affected units have specific serial numbers and were sold with certain GTINs. Read more at govinfonow.com/recall/64931-shanghai-united-imaging-healthcare-uct-530-ct-scanner-recall-uneven.

Source Summary by GovInfoNow · govinfonow.com/recall/64931-shanghai-united-imaging-healthcare-uct-530-ct-scanner-recall-uneven · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2704-2020

Cite this page

“Shanghai United Imaging Healthcare uCT 530 CT Scanner Recall: Uneven Metal Edge Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64931-shanghai-united-imaging-healthcare-uct-530-ct-scanner-recall-uneven. Based on FDA recall #Z-2704-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2704-2020%22&limit=1).

Shanghai United Imaging Healthcare Co., Ltd. recalled Computed Tomography X-ray Systems, Model uCT 530, due to a potential sharp edge hazard, the FDA announced on June 20, 2020.

How to tell if you have it

Brand: Shanghai United Imaging Healthcare
Product: Computed Tomography X-ray System; Model uCT 530
UDI/GTIN: (01) GTIN: 06971576831012
Serial Numbers: SN 300162, 300163, 300174, 300176
Quantity: 4 units

The hazard

The FDA said the metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

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 Philips Spectral CT Recall (Jan. 7, 2026), Philips Brilliance iCT CT Scanner Recall (Jan. 7, 2026) and Philips IQon Spectral CT Recall (Jan. 7, 2026).

How to tell if you have this one

Check for serial numbers 300162, 300163, 300174, or 300176 on the uCT 530 CT scanners. The product was sold with GTIN 06971576831012 and intended for medical imaging.

Brand
Shanghai United Imaging Healthcare
Product
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012
Category
Medical device

FDA recall event · 3 products

All 3 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 including in the states of CA, IN and TX. See uploaded distribution list for more details.

Recall number	Product, codes & lots	Quantity
Z-2703-2020	Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).; SN 600229, 600230, 600232, 600271, 600282	5 units
Z-2704-2020	Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).; SN 300162, 300163, 300174, 300176	4
Z-2705-2020	Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).; SN 353020, 353021, 353023	3

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Look for serial numbers 300162, 300163, 300174, or 300176 on the scanner.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

FDA distribution: “US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Indiana, Texas.

Recall timeline

FDA published this recall 46 days after the firm started it.

Jun 20, 2020Firm started the recall
Jul 27, 2020FDA classified it Class II
Aug 5, 2020Published in FDA’s Enforcement Report

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/64931-shanghai-united-imaging-healthcare-uct-530-ct-scanner-recall-uneven">Shanghai United Imaging Healthcare uCT 530 CT Scanner Recall: Uneven Metal Edge Risk (GovInfoNow)</a>

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-2704-2020 (June 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2704-2020 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.