FDAFDA · Food and drugs·Recall number Z-1054-2024
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Published February 14, 2024 · Recall initiated: December 13, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Distributor
- 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.
- Lot
- UDI-DI: 00884838103627, serial number: 1005.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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