FDA-Device2026-10-14Class IIPROCESSING DEFECT
Philips Spectral CT imaging system recalled for software issues affecting image quality and system motion
What this means
Philips Medical Systems has recalled certain Spectral CT and Spectral CT 7500 RT imaging systems due to software problems. These issues may cause image artifacts, incorrect slice thickness, or unintended movement of the system during operation.
- Contact Philips Medical Systems if you operate one of the affected models (728333, 728340, 728344, or 728345)
- Check your system's software version number and serial number against the recall list
- Do not use the affected system until you receive guidance from Philips
- Request a software update or corrective action from the manufacturer
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
539
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
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.);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0078-2027Want us to check the next one for you?
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