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Terminated

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 reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

FDA Recall Z-0302-2019 · Posted None

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2018-09-04
Date Terminated2020-05-05
Product Quantity61 units

Reason for Recall

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.

Firm Action

Philips notified customers of these issues through Customer Information Letter (CIL) 88200518 to U.S. customers on 9/04/18 receive via USPS Certified mail. notifying them about the issues and temporary solutions available. Non-U.S. customers Non-U.S. customers will receive the letter through Philips Global Markets following local regulations. Field correction will consist of proactive field change order (FCO) release to be deployed to the impacted systems to correct all these issues.customers. if you need any further information or support concerning this issue, contact your local Philips representative. For North America and Canada, contact the Customer Care Solutions Center (1- 800-722-9377, follow the prompts).

Root Cause

Software design

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123599INGENUITY DIGITAL PET/CTPhilips Healthcare (Cleveland) · 2013-07-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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