The Recall Desk
HighFDA (Devices)·Z-1580-2024·Announced 2024-04-24

Philips MRI patient support table floor plate installation defect recall

Philips is recalling 107 Intera 1.5T MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create safety risks during patient use.

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 medical device recall involving a structural installation defect on a patient-support component. The defect presents a risk of patient harm (potential falls or injuries), but no illnesses or injuries have been reported, matching the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Philips North America LLC is recalling 107 Intera 1.5T Master/Nova Magnetic Resonance Systems (MRI systems) due to the patient support table floor plate potentially being incorrectly installed.

The incorrect installation of the floor plate could compromise the structural integrity and stability of the patient support table during clinical use. This may create a hazard when positioning patients for scanning procedures.

The affected systems have specific serial numbers and were distributed worldwide. Healthcare facilities operating affected units should contact Philips for inspection, correction procedures, and guidance on safe continued operation until repairs are completed.

The recalled product

Product
Intera 1.5T Master/Nova, Magnetic Resonance System.
Manufacturer
Philips North America Llc
Hazard
  • installation-defect
  • fall-hazard

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. 781106
  • UDI-DI n/a
  • Serial No. 8648
  • 8650
  • 8400
  • 8668
  • 8849
  • 8788
  • 8754
  • 8603
  • 8733
  • 8488
  • 8928
  • 8866
  • 8224
  • 8368
  • 8254
  • 10131
  • 8379
  • 8827

Distribution

Distributed nationwide across the United States.