FDAClass IINovember 7, 2018

Vereos PET/CT recall: Software Issue

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…

Why was Vereos PET/CT 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
61 units
Distribution
US Nationwide Distribution
Recall date
November 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls