IMPAX — Class II medical device recall Z-0283-2016
Terminated recall by AGFA Healthcare Corp., reported 2015-11-25, distributed in CA, KY, NC, NH, NY, OH, OR, PA…. Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct p
| Recall number | Z-0283-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Healthcare Corp., Greenville, SC, United States |
| Recall initiated | 2015-09-01 |
| Classified | 2015-11-17 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2020-12-15 |
| Distributed | CA, KY, NC, NH, NY, OH, OR, PA, SC, SD, TN, TX, WA |
| Countries outside the US | CA |
| Quantity | 19 |
| Reason classes | software |
| Model numbers | L9M2100 |
Product
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
Reason for recall
Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.
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-0283-2016. 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.