Recall Z-0725-2024— Philips North America Llc

Name: FDA recall Z-0725-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-30

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2023-11-30. It names one FDA 510(k) clearance: K203020. Product: Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.. Reason: Multiple software issues that affect device functionality..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2023-11-30
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 5.0.0.X. Computed Tomography X-Ray System.

Reason for recall

Multiple software issues that affect device functionality.

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