Recall Z-0319-2024— Philips North America

Name: FDA recall Z-0319-2024
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: This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363)..

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

This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).

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