PlainRecalls
FDA Devices Moderate Class II Ongoing

Discovery MR750w 3.0T, whole body magnetic resonance scanner

Reported: December 4, 2024 Initiated: October 28, 2024 #Z-0517-2025

Product Description

Discovery MR750w 3.0T, whole body magnetic resonance scanner

Reason for Recall

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

Details

Recalling Firm
GE Medical Systems, LLC
Units Affected
8 units
Distribution
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
Discovery MR750w 3.0T, whole body magnetic resonance scanner. Recalled by GE Medical Systems, LLC. Units affected: 8 units.
Why was this product recalled?
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 4, 2024. Severity: Moderate. Recall number: Z-0517-2025.