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

Recall Z-1144-2024 — Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; A

U.S. FDA — Device Enforcement · Netherlands · 2024-01-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1144-2024
Date of alert: 2024-01-02
Country / jurisdiction: Netherlands
Risk level: Class II
Risk type: recall
Brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00884838059030

Reported risk: Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.

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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