Drugs & medicalClass II

Agfa Healthcare NV recalls Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and…

Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the…

Read the official notice →
Date
2024-10-16
Country
United States
Brand
Agfa Healthcare NV
Product
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and…
Classification
Class II
Units
US Nationwide distribution. Foreign: Argentina, Australia, Belgium, Chile,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Agfa Healthcare NV recalls

  1. 2023-02-01
  2. US
    Drugs & medicalClass II

    Agfa Healthcare NV recalls Agfa HealthCare Enterprise Imaging XERO Viewer

    There is a software defect that can cause issues with images.

    FDA · DeviceAgfa Healthcare NVDistribution throughout US OUS distribution to Australia, Belgium, Brazil,…Official notice →
All 2 Agfa Healthcare NV recalls →

Other drugs & medical recalls in the United States

  1. 2024-10-23
  2. US
  3. US
    Drugs & medicalClass II

    ACCORD HEALTHCARE, INC. recalls Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare…

    Failed Impurities/Degradation Specifications.

    FDA · DrugACCORD HEALTHCARE, INC.Nationwide within the United States and PROfficial notice →
  4. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L.…

    CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    FDA · DrugBreckenridge Pharmaceutical, IncProduct was distributed nationwide within the United StatesOfficial notice →
  5. 2024-10-16
  6. US
    Drugs & medicalClass II

    Integra LifeSciences Corp. recalls MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube…

    There is a potential for pinholes in the applicator pouch film which creates a sterility concern.

    FDA · DeviceIntegra LifeSciences Corp.Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC,…Official notice →
  7. US
    Drugs & medicalClass II

    MEDLINE INDUSTRIES, LP - Northfield recalls Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket

    CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues,…

    FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the state of CA.Official notice →
  8. US
    Drugs & medicalClass II

    AURIS HEALTH INC recalls Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

    Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure…

    FDA · DeviceAURIS HEALTH INCWorldwide - US Nationwide distribution including in the states of MN, FL, NC,…Official notice →
See all drugs & medical recalls →