IQon Spectral CT with software version 4.7.0 Product recall
IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce…
Why was IQon Spectral CT with software version 4.7.0 Product recalled?
Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.
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?
System Serial Number: 860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860027 860028 860033 860038 860039 860040 860041 860042 860043 860026 860029 860030 860031 860032 860034 860035 860036 860037
- Product
- IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 35
- Distribution
- Worldwide Distribution - US Nationwide in the states of AR, IN, LA, MA, MN, OR, TN & TX. and the countries: Australia, Belgium, Denmark, France, Germany, Israel, Japan, Republic of Korea, Poland, Portugal, Slovenia, Switzerland, Thailand and United Kingdom.
- Recall date
- January 18, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)