FDA-Device2015-07-22Class II
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.
AGFA Healthcare Corp.
Hazard
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.
Sold states
Distributed in the state of MO.
Affected count
2
Manufactured in
10 S Academy St, N/A, Greenville, SC, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2061-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief