The Recall Desk
HighFDA (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.

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 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
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 →

Related recalls

Same manufacturer · Philips North America Llc

See all →

Same hazard · improper installation

See all →