Agency classClass IIOur severity:High FDA (Devices)·Z-1575-2024·Announced 2024-04-24

Philips MRI Patient Support Table Floor Plate May Be Incorrectly Installed

Philips is recalling 347 Intera 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed, potentially compromising patient support stability during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 an FDA Class II medical device recall with a structural installation defect affecting patient support equipment. Although no injuries or illnesses have been reported, an improperly installed support table presents a direct risk of patient harm, consistent with the rubric criterion for high-risk products where injury has not yet occurred.

Plain-English summary

Philips North America LLC is recalling 347 units of the Intera 1.5T Magnetic Resonance (MRI) System due to a potential installation defect affecting the patient support table floor plate.

The patient support table floor plate may be incorrectly installed on affected units. An improper installation could affect the stability and safety of the patient support table during clinical use.

This recall affects Intera 1.5T MRI systems distributed worldwide, including the United States and over 140 other countries. Affected units are identified by specific serial numbers and model numbers (Model Nos. 781195, 781295).

Healthcare facilities operating affected equipment should verify that the patient support table floor plate is properly installed according to manufacturer specifications. Contact Philips for installation verification or corrective action.

The recalled product

Product: Intera 1.5T, Magnetic Resonance System.
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Equipment / MRI
Hazard: improper-installation
structural-defect
fall-risk
Affected units: 347

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. 781195
781295
UDI-DI n/a
Serial No. 30030
18972
18784
18616
18668
18901
30047
18868
18822
18974
18607
18864
18861
18966
18566
18586
18580

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 →

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Same hazard · improper installation