IMPAX Agility — Class II medical device recall Z-2061-2015
Terminated recall by AGFA Healthcare Corp., reported 2015-07-22. Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Ag
| Recall number | Z-2061-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Healthcare Corp., Greenville, SC, United States |
| Recall initiated | 2015-06-26 |
| Classified | 2015-07-13 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2016-01-27 |
| Quantity | 2 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2061-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.