FDA Device recall Z-1662-2014
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation…
- FDA Device
- Class II
- terminated
- Published 2014-06-04
On 2014-06-04 the FDA classified a Class II recall of IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation… by Agfa, citing failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1662-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-30 |
| Published | 2014-06-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Agfa |
| Distribution | SC |
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
Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
Identifiers
| code_info | Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1662-2014%22
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