FDAClass IIAugust 16, 2023

MR 7700 Magnetic Resonance recall

MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

Why was MR 7700 Magnetic Resonance recalled?

The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Number: 782120: UDI-DI: 00884838104112; Serial Numbers: 65041 65031 65030 65025 65023 65019 65013 65009 65008 65007 65006 65005 65004 65003 65002 65000 65020 65012 65034 65001; Product Number 782130: UDI-DI: 00884838104402; Serial Numbers: 45301 45298 45007 45297 45557

Product
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Recalling firm
Philips North America
Quantity
640 total
Distribution
US Nationwide. Global Distribution.
Recall date
August 16, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls