Shanghai United Imaging Healthcare Co., Ltd
Medical device recall Z-1353-2023. Published in FDA’s Enforcement Report on Apr 19, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 19, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 47 systems (U.S. only) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
47 systems (U.S. only), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Models: 88000657 Serial Number/UDI Code: 230003 / 01 06971576832057 240 88000657 21 230003 230005 / 01 06971576832057 240 88000657 21 230005 230007 / 01 06971576832057 240 88000657 21 230007 230012 / 01 06971576832057 240 88000657 21…
Every code shown here, 2,000 characters
Models: 88000657 Serial Number/UDI Code: 230003 / 01 06971576832057 240 88000657 21 230003 230005 / 01 06971576832057 240 88000657 21 230005 230007 / 01 06971576832057 240 88000657 21 230007 230012 / 01 06971576832057 240 88000657 21 230012 230013 / 01 06971576832057 240 88000657 21 230013 230014 / 01 06971576832057 240 88000657 21 230014 230015 / 01 06971576832057 240 88000657 21 230015 230016 / 01 06971576832057 240 88000657 21 230016 230017 / 01 06971576832057 240 88000657 21 230017 230020 / 01 06971576832057 240 88000657 21 230020 230021 / 01 06971576832057 240 88000657 21 230021 230022 / 01 06971576832057 240 88000657 21 230022 230023 / 01 06971576832057 240 88000657 21 230023 230024 / 01 06971576832057 240 88000657 21 230024 230026 / 01 06971576832057 240 88000657 21 230026 230027 / 01 06971576832057 240 88000657 21 230027 230028 / 01 06971576832057 240 88000657 21 230028 230029 / 01 06971576832057 240 88000657 21 230029 230030 / 01 06971576832057 240 88000657 21 230030 230031 / 01 06971576832057 240 88000657 21 230031 230032 / 01 06971576832057 240 88000657 21 230032 230033 / 01 06971576832057 240 88000657 21 230033 230035 / 01 06971576832057 240 88000657 21 230035 230036 / 01 06971576832057 240 88000657 21 230036 230037 / 01 06971576832057 240 88000657 21 230037 230038 / 01 06971576832057 240 88000657 21 230038 230039 / 01 06971576832057 240 88000657 21 230039 230040 / 01 06971576832057 240 88000657 21 230040 230041 / 01 06971576832057 240 88000657 21 230041 230042 / 01 06971576832057 240 88000657 21 230042 230043 / 01 06971576832057 240 88000657 21 230043 230044 / 01 06971576832057 240 88000657 21 230044 230045 / 01 06971576832057 240 88000657 21 230045 230047 / 01 06971576832057 240 88000657 21 230047 230048 / 01 06971576832057 240 88000657 21 230048 Model Number: 88000057 Serial Number/UDI Code: 200017 / 01 06971576832026 240 88000057 21 200017 200023 / 01 06971576832026 240 88000057 21 200023 200024 / 01 06971576832026 240 88000057 21 200024 200036 / 01…
FDA’s list runs to 2,437 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.
The states and territories these words name
- Texas
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 1, 2023.
- FDA classified it on Apr 7, 2023.
- FDA’s Enforcement Report published it on Apr 19, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Shanghai United Imaging Healthcare Co., Ltd., of Shanghai, China.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,437 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.