Skip to content
Recall Observatory FDA recall evidence

Device product

Philips Upgrade to MR 7700 System, Model Number 782130

Z-0463-2023

November 22, 2022

Class II

Product summary

Firm
Philips North America Llc
Event
Event 91195
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0463-2023

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: 00884838104402; Serial Numbers: 45298 45301

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.