Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Recalled by AGFA Healthcare Corp. Due to Firm received a complaint that the hospital had...

Date: June 26, 2015
Company: AGFA Healthcare Corp.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AGFA Healthcare Corp. directly.

Affected Products

IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.

Quantity: 2

Why Was This Recalled?

Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect.

Where Was This Sold?

This product was distributed to 1 state: MO

Affected (1 state)Not affected

About AGFA Healthcare Corp.

AGFA Healthcare Corp. has 12 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report