Spectral CT and Spectral CT 7500 RT Recall: Software Issue
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.);
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Spectral CT and Spectral CT 7500 RT recalled?
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.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
The official FDA identifier list is too long to reproduce here. Compare your item with the complete list in the agency notice.
Which lot codes, UPCs or models are affected?
The official FDA record has an unusually long identifier list. Check the complete lot, serial and model numbers in the linked agency notice.
Open the complete official FDA record
- Agency record number
- Z-0078-2027
- 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.);
- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- Quantity
- 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.
- Recall started
- August 21, 2026
- Report date
- October 14, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)