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Philips Upgrade to MR 7700 System, Model Number 782130

FDA Recall #Z-0463-2023 — Class II — November 22, 2022

Recall #Z-0463-2023 Date: November 22, 2022 Classification: Class II Status: Ongoing

Product Description

Philips Upgrade to MR 7700 System, Model Number 782130

Reason for Recall

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

Recalling Firm

Philips North America Llc — Cambridge, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

N/A

Distribution

US Nationwide.

Code Information

Model 782120: UDI-DI: 00884838104402; Serial Numbers: 45298 45301

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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