Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 19, 2023
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
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 a…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Shanghai United Imaging Healthcare Co., Ltd. recalled Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Compu… - a moderate-severity action.
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Compu… was recalled by Shanghai United Imaging Healthcare Co., Ltd. in April 19, 2023. Reason: Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail w…. Check the official notice for the remedy. Verify recall #Z-1353-2023 with the FDA Devices before acting.
The recall
Shanghai United Imaging Healthcare Co., Ltd. issued this moderate-severity FDA Devices recall-Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail w….
- Moderate
- severity level
- Class II
- classification
- April 19, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1353-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1353-2023) was formally reported on April 19, 2023, with the manufacturer initiating the action on March 1, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Shanghai United Imaging Healthcare Co., Ltd. is listed as the recalling firm, operating out of Shanghai, N/A. Federal records list the affected scope as 47 systems (U.S. only).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
47 systems (U.S. only)
Related Recalls
6
3 from same agency
Product description
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1353-2023 |
| Date reported | April 19, 2023 |
| Date initiated | March 1, 2023 |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Firm location | Shanghai, N/A |
| Affected scope | 47 systems (U.S. only) |
| Distribution | U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1353-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057. Recalled by Shanghai United Imaging Healthcare Co., Ltd.. Units affected: 47 systems (U.S. only).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2023. Severity: Moderate. Recall number: Z-1353-2023.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1353-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 19, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.