Recall Z-1055-2024— PHILIPS MEDICAL SYSTEMS

Name: FDA recall Z-1055-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-13

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS, initiated 2023-12-13. It names one FDA 510(k) clearance: K203020. Product: Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.. Reason: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment..

Recalling firm: PHILIPS MEDICAL SYSTEMS
Classification: Class II
Status: Ongoing
Initiated: 2023-12-13
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K203020 — Spectral CTPhilips Medical Systems Nederland B.V.·cleared 2021-02-26

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 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.

Reason for recall

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

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