AGFA Healthcare Corp. recalls IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provide…

Recall date

June 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2061-2015

FDA classification

Class II

Brand / firm

AGFA Healthcare Corp.

Sold / distributed

Distributed in the state of MO.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.