Recall Z-0292-2024— Philips North America Llc

Name: FDA recall Z-0292-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-09

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2023-10-09. It names one FDA 510(k) clearance: K171850. Product: Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.. Reason: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2023-10-09
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K171850 — Philips CT Big BorePhilips Medical Systems (Cleveland), Inc.·cleared 2017-11-09

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

Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.

Reason for recall

For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

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