Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1069-2013 — 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 mana

U.S. FDA — Device Enforcement · United States · 2013-03-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1069-2013
Date of alert: 2013-03-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: AGFA Corp.
Product category: device
Product type: Devices

Reported risk: Software design error in IMPAX CV 7.8 SU3

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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