Recall Z-0078-2027 ยท JAK System, X-Ray, Tomography, Computed
PHILIPS MEDICAL SYSTEMS
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.);
| Date | Oct 2, 2026 (initiated Aug 21, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by 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 |
| 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, Indones |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K244008 | Spectral CT Philips Medical Systems Technologies , Ltd., May 16, 2025 |