uMI uMI 550 (UDI 06971576832057)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06971576832057), received between Aug 18, 2024 and Aug 18, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Smoking” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

8 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. 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 ↗

2. 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 ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2024Smoking; Smoking

  07:15 AM OF J(B)(6)2024, UIHS CALL CENTER RECEIVED CALL ABOUT PET COOLING ERRORS, UIHS CALL CENTER CSE WORKED WITH SITE TO SHUT DOWN SYSTEM TO RECOVER THE ERROR 2 TIMES WITH FULL POWER OFF. 09:20 AM, LOCAL CSE ARRIVED AT THE SITE FOR DISPATCH. WHEN CSE ARRIVED, HE NOTICED A STRONG SMELL OF ELECTRICAL OZONE AND THE SYSTEM WAS ON. CSE FOUND THAT KC1 RELAY CABLE ASSY WAS CHARRED. THE HALON GAS FIRE SUPPRESSION WAS DEPLOYED. THERE IS NO DISCOLORATION AND DISTORTION ON THE COVER. THERE WAS NO ONE INJURED DUE TO THIS FAILURE. LOCAL CSE CHECKED SYSTEM FAILURE PARTS AND REPLACED WITH SPARE PARTS, AND PASSED QUALITY CHECK ON JULY 3RD,2024. SYSTEM HAS BEEN DELIVERED TO CUSTOMER NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999027 ↗

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-3283-2026 · Aug 11, 2026 · Open, Classified
  Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
• Z-0223-2026 · Sep 12, 2025 · Open, Classified
  Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
• Z-0087-2023 · May 30, 2022 · Open, Classified
  Positron Emission Tomography and Computed Tomography System, Model: uMI 550
• 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-2819-2020 · Mar 26, 2020 · Terminated
  Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthca
• 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