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Philips Medical Systems recalls Spectral CT and Spectral CT 7500 RT

What should I do?

Check whether you have this device (see the product and lot details below). If you do, stop using it and contact the company or your healthcare provider for next steps.

What's the 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.

What's affected

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.);

Read the official FDA Enforcement Report ↗