Lower risk Medical device recall · FDA · Published August 5, 2020

Shanghai United Imaging Healthcare uMI 550 CT Scanner Recall: Incorrect Radiation Exposure

Shanghai United Imaging Healthcare recalls uMI 550 CT scanners due to potential incorrect radiation exposure during scans. Affected units have serial numbers 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004.

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

🇺🇸 FDA recall #Z-0448-2021Medical device Shanghai United Imaging Healthcare ›

Lower-risk recall

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

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 uMI 550 CT scanners because they may display incorrect CT scan delay timers during multi-phase contrast scans. This could lead to unnecessary radiation exposure for operators. The recall affects specific serial numbers listed in the notice. Read more at govinfonow.com/recall/64523-shanghai-united-imaging-healthcare-umi-550-ct-scanner-recall-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/64523-shanghai-united-imaging-healthcare-umi-550-ct-scanner-recall-incorrect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0448-2021

Cite this page

“Shanghai United Imaging Healthcare uMI 550 CT Scanner Recall: Incorrect Radiation Exposure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64523-shanghai-united-imaging-healthcare-umi-550-ct-scanner-recall-incorrect. Based on FDA recall #Z-0448-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0448-2021%22&limit=1).

The FDA announced on 2020-08-05 that Shanghai United Imaging Healthcare Co., Ltd. is recalling nine Positron Emission Tomography and Computed Tomography Systems, Model uMI 550, due to a potential incorrect CT scan delay timer display. This defect could lead operators to receive unnecessary radiation exposure during multi-phase contrast scanning.

How to tell if you have it

Brand: Shanghai United Imaging Healthcare
Product: Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE
GTIN/UPC: 06971576832026
Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004
Distribution: US Nationwide, including TX

The hazard

According to the FDA, a potential issue with an incorrect CT scan delay timer displayed on the gantry Digital Display Panel during multi-phase contrast scanning could lead the operator to receive unnecessary exposure to radiation.

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 Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software (2026-08-11), Shanghai United Imaging Healthcare uMI PET/CT Scanners: Software Issue May Cause Image Reconstruction Failure (2023-03-01), and Shanghai United Imaging Healthcare uMI 550 PET/CT System Recall: Wi-Fi Interference May Cause Scan Failures (2022-05-30). Other recent recalls of similar products include Philips Brilliance CT 64 Medical Scanner Recall, Philips IQon Spectral CT Software 4.7.7.x Recall, and Philips Ingenuity CT Scanners, all announced on 2026-08-07.

How to tell if you have this one

Check if your uMI 550 CT scanner has a serial number listed: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, or 230004.

Brand
Shanghai United Imaging Healthcare
Product
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product
Category
Medical device

FDA recall event · 4 products

All 4 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 state of TX.

Recall number	Product, codes & lots	Quantity
Z-0445-2021	Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).; Serial Numbers: 3000162, 300163, 300174, 300176	4
Z-0446-2021	Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).; Serial Numbers: 353020, 353021, 353023, 353045, 353049	5
Z-0447-2021	Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).; Serial Numbers: 600229, 600230, 600232, 600271, 600282	5
Z-0448-2021	Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - 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.; Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004	9

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Verify your scanner's serial number against the list: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 3 months after the firm started it.

Aug 5, 2020Firm started the recall
Nov 12, 2020FDA classified it Class II
Nov 18, 2020Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/64523-shanghai-united-imaging-healthcare-umi-550-ct-scanner-recall-incorrect">Shanghai United Imaging Healthcare uMI 550 CT Scanner Recall: Incorrect Radiation Exposure (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-0448-2021 (August 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0448-2021 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.