🔍 RecallPedia

IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

Class I - Dangerous
🏥 Medical Devices Recalled: April 30, 2014 AGFA Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - 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:
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
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 Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

Product Codes/Lot Numbers:

Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service

Distribution:

Distributed in: SC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1662-2014

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.

Jun 6, 2014 Diagnostic Equipment Nationwide View Details →