Recall Z-1054-2024— PHILIPS MEDICAL SYSTEMS

Name: FDA recall Z-1054-2024
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: K212875. Product: Spectral CT on Rails: Software Version 5.1.0.X, model 728334.. 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

K212875 — Spectral CT on RailsPhilips Medical Systems Nederland B.V.·cleared 2022-05-13

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 on Rails: Software Version 5.1.0.X, model 728334.

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.