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Device Class II · moderate Ongoing

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.);

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 firmPHILIPS MEDICAL SYSTEMS
ReasonSoftware 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.
Risk classClass II (Class II · moderate)
StatusOngoing
Report dateOct 14, 2026
InitiatedAug 21, 2026
RegionMA, United States
DistributionWorldwide - 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.
Quantity539
Code/Lot1. Model Number: 728333 (U.S.); UDI-DI: 1. 00884838101111, 2. 00884838127876; Serial Numbers: 12055, 12054, 12052, 398006, 12044, 12045, 10237, 10056, 10194, 12059, 10278, 10319, 10143, 10081, 12047,…
TypeVoluntary: Firm initiated
Recall numberZ-0078-2027

Official source

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