Spectral CT on Rails: Software Version 5.1.0.X recall: Software Issue
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Why was Spectral CT on Rails: Software Version 5.1.0.X recalled?
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI: 00884838103627, serial number: 1005.
- Product
- Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- Quantity
- US: 1
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.
- Recall date
- February 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)