PHILIPS MEDICAL SYSTEMS — Class II: Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X
Philips Medical Systems has initiated a Class II recall for Spectral CT and Spectral CT 7500 RT systems due to software issues affecting version numbers 5.0.X, 5.2.X, and 5.4.X. These defects may result in image artifacts, incorrect slice thickness, or unintended system motion.
This recall affects healthcare facilities using Philips Spectral CT systems, specifically model numbers 728333, 728340, 728344, and 728345, as well as radiology departments and software compliance teams.
The reported software issues directly impact the diagnostic integrity of imaging (via artifacts and incorrect thickness) and physical patient safety (via unintended motion). The classification suggests that while the risk of serious injury may be limited, the defects represent a failure to meet performance and safety specifications, necessitating formal corrective action and monitoring of software lifecycle management.
Facility managers and clinical engineers should verify software version numbers against the affected list (5.0.X, 5.2.X, 5.4.X) and coordinate with the manufacturer for necessary patches or mitigations. Quality teams should update risk management files to reflect these specific software-related failure modes.
Class II. 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.. 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.);. Firm: PHILIPS MEDICAL SYSTEMS (Cambridge MA United States). Status: Ongoing.
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