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

Recall Z-0702-2016 — Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysi

U.S. FDA — Device Enforcement · United States · 2015-11-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0702-2016
Date of alert: 2015-11-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Electronics North America Corporation
Product category: device
Product type: Devices

Reported risk: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

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.

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