BEUDAMED
    4 results · 31ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Completed ×

    Azurion systems with software release R2.0.x

    FDA Enforcement
    Class II ·Completed·Philips Healthcare·March 30, 2022

    Azurion systems with software release R2.0.x

    FDA Recall
    Completed ·Philips Healthcare·Product code OWB·May 26, 2021

    IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

    FDA Enforcement
    Class II ·Completed·Philips Healthcare Informatics, Inc.·June 17, 2020

    IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

    FDA Recall
    Completed ·Philips Healthcare Informatics, Inc.·Product code LLZ·April 19, 2019