[Recalled] Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 — This recall is part of a 2-issue recall for the same system | FDA 2023-10-09

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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).

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Philips North America

• Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. — Class II
• Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY); — Class II
• Intera 1.5T Achieva Nova. Model (REF) Numbers 781172. — Class II
• SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1. — Class II
• Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1. — Class II
• Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163. — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.