Company: PHILIPS MEDICAL SYSTEMS
Date of Enforcement Report: 10/2/2026
Class: II

PRODUCT

Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.);

Recall Number:

Z-0078-2027

REASON:

Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.

RECALLING FIRM/MANUFACTURER:

PHILIPS MEDICAL SYSTEMS

VOLUME:

539

DISTRIBUTION:

Worldwide – US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MD, MN, NC, NY, OH, PA, TX, VA, WV and the countries of Australia, Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lithuania, Macao, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Nicaragua, Norway, Palestine, Panama, Philippines, Poland, Portugal, Romania, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.