The Recall Desk
HighFDA (Devices)·Z-1551-2024·Announced 2024-04-24

Philips Achieva MRI Patient Support Table Floor Plate Installation Defect

Philips is recalling 115 Achieva 1.5T MRI systems due to potential incorrect installation of the patient support table floor plate.

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 recall involves a risk-of-harm product (patient support medical equipment) where no injury has been reported. The FDA Class II classification reflects the seriousness of the structural installation defect without reported hospitalizations.

Plain-English summary

Philips North America LLC is recalling the Achieva 1.5T Conversion Magnetic Resonance System due to an installation issue with the patient support table floor plate.

The patient support table floor plate may be incorrectly installed on affected units. Approximately 115 units are affected. The affected systems have been distributed worldwide.

The recalled product

Product
Achieva 1.5T Conversion, 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. 781283
  • 781346
  • UDI-DI n/a
  • Serial No. 39025
  • 8020
  • 39027
  • 39060
  • 39016
  • 39079
  • 39022
  • 39001
  • 8467
  • 39013
  • 39006
  • 39004
  • 39007
  • 39008
  • 39011
  • 39010
  • 39012

Distribution

Distributed nationwide across the United States.