Recall Z-2034-2025— Philips North America Llc

Name: FDA recall Z-2034-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-29

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2025-05-29. It names one FDA 510(k) clearance: K203020. Product: Spectral CT. Computed tomography X-ray system.. Reason: Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2025-05-29
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. Computed tomography X-ray system.

Reason for recall

Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.

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