🔍 RecallPedia

Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM

Class I - Dangerous
🏥 Medical Devices Recalled: October 24, 2014 AGFA Healthcare Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot 79440009
  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 Healthcare Corp.
Reason for Recall:
Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM

Product Codes/Lot Numbers:

Lot 79440009

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0804-2015

Related Recalls

Agfa Healthcare NX 3.0.8950 Imaging Processing Software

AGFA Healthcare

Class I - Dangerous

A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS.

Dec 21, 2016 Diagnostic Equipment Nationwide View Details →

IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats

AGFA Healthcare

Class I - Dangerous

A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.

Dec 22, 2016 Other Medical Devices Nationwide View Details →