IMPAX CV Pediatric Echo Reporting — Class II medical device recall Z-1662-2014
Terminated recall by AGFA Corp., reported 2014-06-04. Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8
| Recall number | Z-1662-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AGFA Corp., Greenville, SC, United States |
| Recall initiated | 2014-04-30 |
| Classified | 2014-05-27 |
| Reported by FDA | 2014-06-04 |
| Terminated | 2014-09-18 |
| Reason classes | software |
| Model numbers | L9M21000 |
Product
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
Reason for recall
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
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-1662-2014. 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.