Recall Z-0583-2025— Philips North America Llc

Name: FDA recall Z-0583-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-16

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2024-11-16. It names one FDA 510(k) clearance: K203020. Product: Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.. Reason: Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2024-11-16
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 and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.

Reason for recall

Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

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