Reported Jul 22, 2015 · Terminated
IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS)…
AGFA Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AGFA Healthcare Corp. · 10 S Academy St · Greenville, SC · 29601-2632
Is this the product you have?
- 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.
- Lot codes and dates
- N/A
- Amount recalled
- 2
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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