Recall Z-0078-2027— PHILIPS MEDICAL SYSTEMS

Name: FDA recall Z-0078-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-21

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS, initiated 2026-08-21. It names one FDA 510(k) clearance: K244008. 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.);. 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..

Recalling firm: PHILIPS MEDICAL SYSTEMS
Classification: Class II
Status: Ongoing
Initiated: 2026-08-21
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K244008 — Spectral CTPhilips Medical Systems Technologies , Ltd.·cleared 2025-05-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.);

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.