Drugs & medicalClass II

Shanghai United Imaging Healthcare Co., Ltd. recalls 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…

Read the official notice →
Date
2022-10-19
Country
United States
Brand
Shanghai United Imaging Healthcare
Product
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Classification
Class II
Units
Distribution to US states of TX, WI, CA, and MI
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Shanghai United Imaging Healthcare recalls

  1. 2026-10-07
  2. US
    Drugs & medicalClass II

    Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System, Model: uCT 530 with software

    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…

    FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX,…Official notice →
  3. 2023-04-19
  4. US
    Drugs & medicalClass II

    Shanghai United Imaging Healthcare Co., Ltd. recalls Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model…

    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 · DeviceShanghai United Imaging Healthcare Co., Ltd.U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.Official notice →
  5. 2022-05-18
  6. US
    Drugs & medicalClass II

    Shanghai United Imaging Healthcare Co., Ltd. recalls Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

    X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat…

    FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.US Nationwide distribution in the state of TX.Official notice →
  7. 2021-10-06
  8. US
    Drugs & medicalClass II

    Shanghai United Imaging Healthcare Co., Ltd. recalls uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in…

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

    FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.Official notice →
All 5 Shanghai United Imaging Healthcare recalls →

Other drugs & medical recalls in the United States

  1. 2022-10-26
  2. US
    Drugs & medicalClass II

    Ingenus Pharmaceuticals Llc recalls Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL…

    Out of specification for related substances (impurities).

    FDA · DrugIngenus Pharmaceuticals LlcNationwide within the United StatesOfficial notice →
  3. 2022-10-25
  4. US
    Drugs & medical

    Clorox® Recalls Pine-Sol® Scented Multi-Surface Cleaners, CloroxPro® Pine-Sol® All Purpose Cleaners, and Clorox® Professional™ Pine-Sol® Lemon Fresh Cleaners Due to…

    The recalled products may contain bacteria, including Pseudomonas aeruginosa, an environmental organism found widely in soil and water. People with weakened immune systems or external medical devices who are exposed to…

    CPSCThe Clorox Company, of Oakland, CaliforniaTo date, testing has identified bacteria in certain…Official notice →
  5. 2022-10-19
  6. US
    Drugs & medicalClass II

    MEDLINE INDUSTRIES, LP - Northfield recalls VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.

    Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET INTRO 6.5FX12CM FITS 0.018, instead of a 7cm…

    FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldCAOfficial notice →
  7. US
    Drugs & medicalClass II

    Johnson & Johnson Surgical Vision, Inc. recalls Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

    As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

    FDA · DeviceJohnson & Johnson Surgical Vision, Inc.Worldwide Distribution. US states of AL, AR, AZ, CA, CO, DE, FL, GA, HI, IL…Official notice →
  8. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.

    Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight…

    FDA · DeviceBaxter Healthcare CorporationUS NationwideOfficial notice →
  9. US
    Drugs & medicalClass II

    LUMINOSTICS, INC dba CLIP HEALTH recalls Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002

    COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.

    FDA · DeviceLUMINOSTICS, INC dba CLIP HEALTHUS nationwide distributionOfficial notice →
See all drugs & medical recalls →