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Recall Observatory FDA recall evidence

Device product

Philips MR 7700 System, Model Number 782120

Z-0462-2023

November 22, 2022

Class II

Product summary

Firm
Philips North America Llc
Event
Event 91195
Status
Ongoing
Classification
Class II
Quantity
566 total
Official record key
device-enforcement:Z-0462-2023

Official wording

Reason: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

Code information: Model 782120: UDI-DI: 00884838104112; Serial Numbers: 65005 65006 65007 65008

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.