Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
FDA Recall #Z-1054-2024 — Class II — December 13, 2023
Product Description
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Reason for Recall
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Recalling Firm
PHILIPS MEDICAL SYSTEMS — Cambridge, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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.
Code Information
UDI-DI: 00884838103627, serial number: 1005.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated