Agency classClass IIOur severity:High FDA (Devices)·Z-1556-2024·Announced 2024-04-24

Philips Achieva XR MRI recalled for incorrectly installed patient support table floor plate

Philips is recalling 49 Achieva XR magnetic resonance imaging systems worldwide due to an incorrectly installed patient support table floor plate that may affect equipment stability and patient safety.

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 involving a structural installation defect on patient support equipment. Although no injuries or deaths have been reported, the defect affects equipment that directly supports patients during medical imaging procedures, creating a risk of patient harm if the floor plate fails during use.

Plain-English summary

Philips North America LLC is recalling 49 units of the Achieva XR Magnetic Resonance System (MRI) due to a defect affecting the patient support table floor plate. The floor plate may be incorrectly installed, which could compromise the stability and proper functioning of the equipment during patient procedures.

This recall affects systems with model numbers 781153 and 781253 that were distributed worldwide, including throughout the United States and internationally to over 80 countries. Affected serial numbers are documented in the FDA recall notice.

Facilities with affected units should immediately contact Philips North America LLC for inspection, correction, or replacement of the floor plate assembly. Equipment should not be used for patient procedures until the floor plate installation has been verified and corrected by qualified Philips service personnel.

The recalled product

Product: Achieva XR, Magnetic Resonance System.
Manufacturer: Philips North America Llc
Category: Medical Device — Medical Imaging Equipment
Hazard: installation-defect
structural-defect
equipment-failure-risk
Affected units: 49

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. 781153
781253
UDI-DI n/a
Serial No. 35075
23028
23017
23021
35006
35015
35016
35021
23009
23003
23031
23005
23035
23040
35007
35022
35025

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 · installation defect