Agency classClass IIOur severity:High FDA (Devices)·Z-1552-2024·Announced 2024-04-24

Philips Achieva 1.5T MRI System: Patient Support Table Floor Plate Installation Issue

Philips is recalling 69 units of the Achieva 1.5T Initial MRI system due to potential issues with the patient support table floor plate installation, which may affect patient safety during imaging.

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 FDA Class II medical device recall involves a structural installation issue on patient-support equipment that could affect user safety. No illnesses or injuries have been reported. The score reflects the criteria for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling 69 units of the Achieva 1.5T Initial Magnetic Resonance System due to a potential installation issue with the patient support table floor plate.

The patient support table floor plate may be incorrectly installed in affected units. If not properly installed, this could compromise the safety and stability of the patient support system during MRI procedures.

The recalled units were distributed worldwide, including throughout the United States and to multiple countries across North America, Europe, Asia, Africa, and Oceania.

Healthcare facilities with affected units should contact Philips North America LLC for guidance on inspecting the patient support table floor plate installation and obtaining corrective measures.

The recalled product

Product: Achieva 1.5T Initial, Magnetic Resonance System.
Manufacturer: Philips North America Llc
Category: Medical Device — MRI System
Hazard: improper-installation
structural-defect
Affected units: 69

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. 781178
UDI-DI n/a
Serial No. 20126
20129
20062
20297
20307
20150
20248
20096
20252
20257
20282
20149
20072
20277
20281
20185
20081
20018

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