High FDA (Devices)·Z-1588-2024·Announced 2024-04-24

Magnetic Resonance System Patient Support Table Floor Plate Installation Issue

Philips is recalling the MR 7700 Magnetic Resonance System due to potential incorrect installation of the patient support table floor plate. The recall affects 26 units distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is classified as FDA Class II with no reported illnesses or injuries. The incorrect installation of a patient support table floor plate constitutes a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity rating.

Plain-English summary

Philips North America LLC is recalling the MR 7700 Magnetic Resonance System. The recall affects 26 units distributed worldwide, including throughout the United States and multiple other countries.

The patient support table floor plate on affected units may have been incorrectly installed. The patient support table is the component used to position patients during magnetic resonance imaging procedures.

For detailed information about this recall and any associated guidance, refer to FDA recall number Z-1588-2024.

The recalled product

Product: MR 7700, Magnetic Resonance System.
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging
Hazard: installation-error
Affected units: 26

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model No. 782120
UDI-DI 884838104112
Serial No. 65051
65005
65000
65002
65003
65001
65004
65009
65012
65013
65015
65017
65020
65019
65021
65023
65024
65025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 41 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 41 products in this recall →

Same manufacturer · Philips North America Llc

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