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

FDA device recall Z-0319-2024 · posted 2023-11-16 · Open, Classified

Recall details

Recalling firm

Philips North America

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).

Action taken

An URGENT Medical Device Correction notification letter dated 10/9/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users Below are short-term precautions to take until the permanent solution is installed. Remain vigilant and confirm gantry position during procedures. Review the Emergency Stop Procedure and Collision Prevention Guidelines provided in Section 6: Working with Specialized Exams of the IFU. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the software update (FCO 72800805) to resolve the issue. Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JAK

Quantity affected

1 unit

Distribution

US Nationwide distribution in the state of MN.

Date initiated

2023-10-09

Date posted

2023-11-16

Location

Cambridge, MA

Related 510(k) clearances