Company: PHILIPS MEDICAL SYSTEMS
Date of Enforcement Report: 2/8/2024
Class II
PRODUCT
Spectral CT on Rails: Software Version 5.1.0.X, model 728334
Recall Number:
Z-1054-2024
REASON:
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
RECALLING FIRM/MANUFACTURER:
PHILIPS MEDICAL SYSTEMS
VOLUME OF PRODUCT IN COMMERCE:
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.
