Shanghai United Imaging Healthcare Co., Ltd. recall records

2 reported ongoing

2 records in this archive. Latest source date Mar 1, 2023.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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 and generation of PET images.

Class IIReported ongoing

Distribution: U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.

Official source for Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomo...
FDA device enforcement

Positron Emission Tomography and Computed Tomography System, Model: uMI 550

The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the f...

Class IIReported ongoing

Distribution: Distribution to US states of TX, WI, CA, and MI

Official source for Positron Emission Tomography and Computed Tomography System, Model: uMI 550

Reasons in these listed records

  • 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.
  • The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and re...

These examples come from this result page and are not a ranking of every recall reason.

Checking Shanghai United Imaging Healthcare Co., Ltd.

Is there a recall on shanghai united imaging healthcare co., ltd. right now?

This archive contains 2 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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