Recall Z-1756-2024— Philips North America Llc

Name: FDA recall Z-1756-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-29

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2024-03-29. It names one FDA 510(k) clearance: K203020. Product: The Oncology Essentials Package of the Spectral CT imaging system.. Reason: Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2024-03-29
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

The Oncology Essentials Package of the Spectral CT imaging system.

Reason for recall

Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.

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