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

Recall Z-1662-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2014-04-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1662-2014
Date of alert: 2014-04-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: AGFA Corp.
Product category: device
Product type: Devices

Reported risk: Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

Recall Z-1662-2014 — 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.

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