Agency classClass IIOur severity:High FDA (Devices)·Z-1550-2024·Announced 2024-04-24

Philips Achieva 1.5T MRI Systems Recalled Due to Incorrect Support Table Installation

Philips is recalling 1,921 Achieva 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed. Healthcare facilities should verify proper installation.

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 a Class II FDA medical device recall with a potential patient safety hazard (incorrect installation of the patient support table structural component). No injuries or illnesses have been reported in the source text, meeting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling 1,921 units of the Achieva 1.5T Magnetic Resonance System due to a potential installation defect. The patient support table floor plate may be incorrectly installed on affected systems.

This recall affects systems distributed worldwide, including in the United States and numerous countries internationally. The affected systems include Model Numbers 781196, 781296, and 781343, along with the associated serial numbers listed in the recall notice.

Healthcare facilities and imaging centers using affected MRI systems should verify the installation of the patient support table floor plate. Contact Philips to correct any installation defects that may be identified to ensure safe operation.

The recalled product

Product: Achieva 1.5T, Magnetic Resonance System.
Manufacturer: Philips North America Llc
Category: Medical Device — Magnetic Resonance Imaging
Hazard: installation-defect
structural-defect
Affected units: 1,921

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. 781196
781296
781343
UDI-DI n/a
Serial No. 32508
21935
32084
22167
21313
21681
32550
32717
32083
22136
22319
32095
32481
22001
21237
21968

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 · installation defect