Philips North America: Device Recall

Recall #Z-1931-2025 · 05/29/2025

Class II: Risk

Recall Details

Recall Number
Z-1931-2025
Classification
Class II
Product Type
Device
Recalling Firm
Philips North America
Status
Ongoing
Date Initiated
05/29/2025
Location
Cambridge, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units (1 US, 2 OUS)

Reason for Recall

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.

Product Description

Intera 1.5T Achieva Nova-Dual Product Number: 781173;

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.

Other Recalls by Philips North America

View all recalls by Philips North America →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.