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

Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). — recall Z-0704-2016

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-0704-2016
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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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.