FDA Device recall Z-1069-2013
IMPAX CV 7.8 SU3 - OCR Service
- FDA Device
- Class II
- terminated
- Published 2013-04-17
On 2013-04-17 the FDA classified a Class II recall of IMPAX CV 7.8 SU3 - OCR Service by Agfa, citing software design error in IMPAX CV 7.8 SU3.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1069-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-15 |
| Published | 2013-04-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Agfa |
| Distribution | FL, KY |
Product
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.
Reason
Software design error in IMPAX CV 7.8 SU3
Identifiers
| code_info | Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (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-1069-2013%22
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