PlainRecalls
FDA Devices Moderate Class II Ongoing

SmartPath to dStream for 1.5T

Reported: November 29, 2023 Initiated: October 23, 2023 #Z-0395-2024

Product Description

SmartPath to dStream for 1.5T

Reason for Recall

Potential component failure in the Gradient Coil could product smoke and/or fire.

Details

Recalling Firm
Philips North America Llc
Units Affected
119 units
Distribution
Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
SmartPath to dStream for 1.5T. Recalled by Philips North America Llc. Units affected: 119 units.
Why was this product recalled?
Potential component failure in the Gradient Coil could product smoke and/or fire.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 29, 2023. Severity: Moderate. Recall number: Z-0395-2024.