Agency classClass IIOur severity:High FDA (Devices)·Z-1577-2024·Announced 2024-04-24

Philips Intera 1.5T MRI Patient Support Table Floor Plate Installation Defect

Philips is recalling 46 units of the Intera 1.5T Achieva Nova MRI system due to improper installation of the patient support table floor plate. The defect may compromise patient safety 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: FDA Class II medical device recall with a structural installation defect affecting patient support equipment. No reported injuries or hospitalizations are documented in the source. The defect presents a risk of patient harm if not corrected, meeting the criterion for risk-of-harm products without reported injury.

Plain-English summary

Philips North America LLC is recalling 46 units of the Intera 1.5T Achieva Nova Magnetic Resonance System (MRI) due to a potential safety issue with the patient support table floor plate.

The patient support table floor plate may be incorrectly installed on affected units. This defect could compromise the stability and safety of the patient table during MRI procedures.

The recalled systems were distributed worldwide, including throughout the United States and over 100 additional countries. Facility operators using affected Intera systems should verify the proper installation of the patient support table floor plate and contact Philips for corrective measures if needed.

The recalled product

Product: Intera 1.5T Achieva Nova, Magnetic Resonance System.
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: improper-installation
patient-fall-risk
Affected units: 46

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. 781172
UDI-DI n/a
Serial No. 12144
12075
12031
12015
12056
12051
12107
12078
12065
12045
12046
12026
12105
12062
12111
12077
12044
12049

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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Same hazard · improper installation