Events

Recall of IMPAX DS3000

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AGFA HEALTHCARE CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    22838
  • Event Risk Class
    II
  • Event Initiated Date
    2007-06-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Text area synchronization lock feature can fail : with "lock" engaged the text and image areas can be "out of synchronization".

Device

IMPAX DS3000
  • Model / Serial
    Model Catalog: ED4Q8 000 (Lot serial: same as previously); Model Catalog: IMPAX 6.2 (EWMDT) (Lot serial: Mammo Techni concurrent EW48N); Model Catalog: IMPAX6.2 (Lot serial: Mammo Techni concurrent EW48N); Model Catalog: IMPAX 6.2 (EWMDT) (Lot serial: Breast Imag Rd QC Conc L8DLU); Model Catalog: IMPAX6.2 (Lot serial: Breast Imag Rd QC Conc L8DLU); Model Catalog: IMPAX 6.2 (EWMDT) (Lot serial: Breast Imag Rad Concur L8DGM); Model Catalog: IMPAX6.2 (Lot serial: Breast Imag Rad Concur L8DGM); Model Catalog: IMPAX 6.2 (EWMDT) (Lot serial: Radiolog QC Concurrent EW43C); Model Catalog: IMPAX6.2 (Lot serial: Radiolog QC Concurrent EW43C); Model Catalog: IMPAX 6.2 (EWMDT) (Lot serial: Radiologist Concurrent L8DTC); Model Catalog: IMPAX6.2 (Lot serial: Radiologist Concurrent L8DTC); Model Catalog: IMPAX 6.2 (EWMDT) (Lot serial: Product codes for IMPAX 6.2.1); Model Catalog: IMPAX6.2 (Lot serial: Product codes for IMPAX 6.2.1); Model Catalog: L4AW6 (Lot serial: Enterprise unlimited L8DQ5); Model Catalog: IMPAX MA3000
  • Product Description
    IMPAX 6.2.1 Syst.-Impas DS3000
  • Manufacturer
    AGFA HEALTHCARE CORPORATION

Manufacturer

AGFA HEALTHCARE CORPORATION
  • Manufacturer Address
    GREENVILLE
  • Manufacturer Parent Company (2017)
    Agfa-Gevaert NV
  • Source
    HC