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

IMPAX RIS QDOC 5.8 — recall Z-0919-2014

U.S. FDA — Device Enforcement · United States · 2014-01-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0919-2014
Date of alert
2014-01-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
AGFA Corp.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
Reported risk: Patient name displayed (printed) on the Patient Report was the wrong patient name.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.