The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1553-2024·Announced 2024-04-24

Philips Achieva 3.0T MRI System Patient Support Table Floor Plate Installation Defect

Philips has recalled 511 units of the Achieva 3.0T Magnetic Resonance System due to a potential installation defect in the patient support table floor plate, which could affect table stability and patient safety.

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 affects 511 units of equipment that directly supports patients during diagnostic imaging. An incorrectly installed patient support table floor plate presents a risk of patient harm through potential table instability, meeting the criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling the Achieva 3.0T Magnetic Resonance System due to a potential installation defect. The patient support table floor plate may be incorrectly installed on affected units, which could compromise the structural stability of the patient support component.

A total of 511 units have been recalled with worldwide distribution, including throughout the United States and more than 100 countries. The Achieva 3.0T is a diagnostic magnetic resonance imaging system used in healthcare facilities.

This is classified as an FDA Class II recall.

The recalled product

Product
Achieva 3.0T, Magnetic Resonance System.
Manufacturer
Philips North America Llc
Category
Medical Device — Medical Imaging
Hazard
Affected units
511

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. 781177
  • 781277
  • 781278
  • 781344
  • 781345
  • UDI-DI n/a
  • Serial No. 17108
  • 24070
  • 24114
  • 34066
  • 24053
  • 17235
  • 17256
  • 17244
  • 17114
  • 34028
  • 38018
  • 17049
  • 17217
  • 38033

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 →

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