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Open, Classified

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.);

FDA Recall Z-0078-2027 · Posted 2026-10-02

Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2026-08-21
Product Quantity539

Reason for Recall

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.

Firm Action

On August 21, 2026, URGENT Medical Device Correction letters were sent to customers. Customer actions: User Instructions Philips recommends the following actions be taken for continued safe use of the device: 1. Continue to use your system(s) in accordance with the intended use; 2. Circulate this notice to all users of the device so that they are aware of the product issues, associated potential hazards, and manufacturer recommendations (refer to Table 1 and Table 2 for specific details regarding recommended actions); 3. Post this notice near the affected unit(s) for ease of reference until a solution is installed on your system. 4. Please complete and return the attached response form within 30 days to confirm receipt and understanding of this notice.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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