🔍 RecallPedia

IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

Class I - Dangerous
🏥 Medical Devices Recalled: March 15, 2013 AGFA Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
AGFA Corp.
Reason for Recall:
Software design error in IMPAX CV 7.8 SU3
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

Product Codes/Lot Numbers:

Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service

Distribution:

Distributed in: FL, KY

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1069-2013

Related Recalls

AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.

AGFA

Class I - Dangerous

When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.

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