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Recall Observatory FDA recall evidence

Device product

Discovery MR750w 3.0T, whole body magnetic resonance scanner

Z-0517-2025

October 28, 2024

Class II

Product summary

Firm
GE Medical Systems, LLC
Event
Event 95735
Status
Ongoing
Classification
Class II
Quantity
8 units
Official record key
device-enforcement:Z-0517-2025

Official wording

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

Code information: System ID 760724DVMR1, UDI/DI To be provided; System ID 214820TS750WMR, UDI/DI To be provided; System ID 281333MR2, UDI/DI To be provided; System ID 82427240081, UDI/DI (01)00840682103817(11)181200(21)PG75W1800047SC; System ID 82427120136, UDI/DI Not Applicable; System ID 82427200092, UDI/DI To be provided; System ID 82427250061, UDI/DI To be provided; System ID EM0232, UDI/DI Not Applicable

Distribution pattern: Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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

Field note

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