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

Recall Z-0302-2019 — Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer

U.S. FDA — Device Enforcement · United States · 2018-09-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0302-2019
Date of alert: 2018-09-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Medical Systems (Cleveland) Inc
Product category: device
Product type: Devices

Reported risk: Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors that may result in partial set of images, inability to generate CT or PET images, incorrect scan parameters, or scanning the incorrect portion of the body.

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

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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.

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