uMI uMI 550 (UDI 06971576832026)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

6 FDA recall records name this device's identifier, 5 still open.

4 other recalls cover devices cleared under the same FDA submission (K182237, K193210, K193241, K210001, K210418); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 11, 2026Open, Classified

   Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.

   Z-3283-2026 · Root cause: Software design · FDA record ↗

2. Sep 12, 2025Open, Classified

   Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

   Z-0223-2026 · Root cause: Other · FDA record ↗

3. Mar 1, 2023Open, Classified

   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.

   Z-1353-2023 · Root cause: Software design · FDA record ↗

4. May 30, 2022Open, Classified

   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 respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.

   Z-0087-2023 · Root cause: Device Design · FDA record ↗

5. Aug 2, 2021Open, Classified

   The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

   Z-2593-2021 · Root cause: Device Design · FDA record ↗

6. Mar 26, 2020Terminated

   In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.

   Z-2819-2020 · Root cause: Software design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182237, K193210, K193241, K210001, K210418. One submission often covers many models, so check the product and lot details in each record.

• Z-2594-2021 · Aug 2, 2021 · Open, Classified
  uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, trea
• Z-0448-2021 · Aug 5, 2020 · Open, Classified
  Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professio
• Z-2800-2020 · Jul 16, 2020 · Terminated
  uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, dia
• Z-1708-2020 · Aug 26, 2019 · Terminated
  Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: Thi