The Recall Desk
HighFDA (Devices)·Z-1796-2021·Announced 2021-06-16

Diagnostic MR imaging system hoisting blocks mechanical defect

Philips is recalling 156 Ingenia Ambition S diagnostic MR systems due to a mechanical issue detected in the lifting blocks on the magnet used during equipment movement and decommissioning.

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 an FDA Class II recall involving a mechanical defect in structural hoisting equipment (lifting blocks on the magnet). No injuries or illnesses have been reported in the source; the hazard remains theoretical, placing this at the highest level for recalls without reported incidents.

Plain-English summary

Philips North America LLC is recalling 156 Ingenia Ambition S diagnostic magnetic resonance (MR) systems, Model Number 781359, due to a mechanical issue detected in the lifting blocks on the magnet.

The MR systems are equipped with four lifting blocks positioned on top of the magnet. These blocks are designed to allow the magnet to be lifted and moved by crane equipment during decommissioning or relocation activities. A mechanical defect has been identified in these hoisting interface blocks.

The recalled systems have been distributed domestically to healthcare facilities in the following U.S. states: Florida, Georgia, Michigan, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Texas, and Vermont. Internationally, units have been distributed to Australia, Austria, Bangladesh, Belgium, Brazil, Denmark, Finland, France, Germany, Iraq, Italy, Japan, Libya, Moldova, Netherlands, Oman, Spain, Switzerland, Thailand, United Arab Emirates, and United Kingdom.

Healthcare facilities with these systems should be aware of this Class II recall and review recall communications from Philips regarding the mechanical issue in the hoisting interface blocks.

The recalled product

Product
Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.
Manufacturer
Philips North America Llc
Hazard
  • mechanical-defect
  • equipment-failure

Distribution

Distributed in 11 states:

  • FL
  • GA
  • MI
  • MO
  • NH
  • NJ
  • NY
  • PA
  • SC
  • TX
  • VT