The Recall Desk
HighFDA (Devices)·Z-1554-2024·Announced 2024-04-24

Philips Achieva 3.0T MRI Patient Support Table Floor Plate May Be Incorrectly Installed

Philips is recalling one Achieva 3.0T for PET MRI system with a patient support table floor plate that may be incorrectly installed.

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: Class II recall for a medical device with an installation defect affecting patient-facing equipment. No illnesses or injuries have been reported, but the incorrect installation of a patient support component poses a potential risk of harm to patients and staff. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Philips North America LLC is recalling one Achieva 3.0T for PET Magnetic Resonance System (Model 781477, Serial Number 43006). The patient support table floor plate may be incorrectly installed on this unit.

The device was distributed worldwide, including throughout the United States and numerous other countries.

This is classified as a Class II recall by the FDA.

The recalled product

Product
Achieva 3.0T for PET, Magnetic Resonance System.
Manufacturer
Philips North America Llc
Category
Medical Device — MRI System
Hazard
  • installation-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 (3)

  • Model No. 781477
  • UDI-DI n/a
  • Serial No. 43006.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category