The Recall Desk
HighFDA (Devices)·Z-1568-2024·Announced 2024-04-24

Philips Ingenia Ambition S MRI Patient Support Floor Plate May Be Incorrectly Installed

Philips is recalling 344 Ingenia Ambition S MRI systems because the patient support table floor plate 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: Medical equipment support table is a risk-of-harm product; incorrect installation could compromise patient safety during operation. However, no incidents or injuries have been reported. FDA classified this as Class II.

Plain-English summary

Philips North America Llc has recalled 344 units of the Ingenia Ambition S Magnetic Resonance System worldwide due to a potential issue with the patient support table floor plate.

The patient support table floor plate may be incorrectly installed on affected units. The recalled systems include Model Numbers 782133, 782139, 781359, and 782108.

The recall affects systems distributed throughout the United States and globally, including countries in Europe, Asia, the Middle East, Africa, the Americas, and Oceania.

Healthcare facilities and practitioners with an affected Ingenia Ambition S system should contact Philips North America Llc to verify the proper installation of the patient support table floor plate and determine if corrective action is needed.

The recalled product

Product
Ingenia Ambition S, Magnetic Resonance System.
Manufacturer
Philips North America Llc
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 (20)

  • Model No. 782133
  • 782139
  • 781359
  • 782108
  • UDI-DI 884838090057
  • 884838098343
  • 884838108639
  • Serial No. 48646
  • 48700
  • 48237
  • 48665
  • 48179
  • 48120
  • 48645
  • 48252
  • 48217
  • 48648
  • 48708
  • 48162
  • 48688

Distribution

Distributed nationwide across the United States.