Recall Z-2061-2015— AGFA Healthcare Corp.
Class II · Terminated
Class II FDA medical device recall by AGFA Healthcare Corp., initiated 2015-06-26, terminated 2016-01-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- AGFA Healthcare Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-26
- Terminated
- 2016-01-27
- Firm location
- Greenville, SC, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.