The Recall Desk
HighFDA (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.

What this means for you

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
Hazard
  • installation-defect
  • structural-defect

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.