—#167661

Product

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 product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123599
Affected lot / code info: Serial Numbers: 900004 900005 900006 900007 900008 900009 900010 900011 900012 900013 900014 900015 900016 900017 900018 900019 900020 900021 900022 900023 900024 900025 900026 900027 900028 900029 900030 900031 900032 900033 900034 900035 900036 900037 900038 900039 900040 900041 900042 900043 900044 900045 900046 900047 900048 900049 900050 900051 900052 900053 900054 900055 900056 900058 900059 900060 900062 900064 900065 900066 900067

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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).

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2018-09-04
Terminated: 2020-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167661. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.