Recall Z-0306-2024— Philips North America

Name: FDA recall Z-0306-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-09

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2023-10-09. It names one FDA 510(k) clearance: K212875. Product: Spectral CT on Rails, Software Version 5.1.0, Model Number 728334. Reason: When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted..

Recalling firm: Philips North America
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

K212875 — Spectral CT on RailsPhilips Medical Systems Nederland B.V.·cleared 2022-05-13

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 on Rails, Software Version 5.1.0, Model Number 728334

Reason for recall

When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

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