FDAClass IIMarch 14, 2018

IQon Spectral CT with 4.7.2 software version recall: Software Issue

IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

Why was IQon Spectral CT with 4.7.2 software version recalled?

23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.

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: 860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860025 860026 860027 860028 860029 860030 860031 860032 860033 860034 860035 860036 860037 860038 860039 860040 860041 860042 860043 860046 860048 860049 860050 860051 860052 860053 860054 860055 860056 860057 860058 860059 860060 860061 860062 860063 860064 860065 860066 860067 860068 860070 860071 860072 890002 860047

Product
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
63
Distribution
Domestic and Foreign
Recall date
March 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls