Philips North America: Medical Device Recall in 2023 - (Recall #: Z-0319-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Product Classification:

Class II

Date Initiated: October 9, 2023

Date Posted: November 22, 2023

Recall Number: Z-0319-2024

Event ID: 93362

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).

Status: Ongoing

Product Quantity: 1 unit

Code Information:

UDI-DI: 00884838103627; Lot Code: 1005

Distribution Pattern:

US Nationwide distribution in the state of MN.

Voluntary or Mandated:

Voluntary: Firm initiated