Ingenia Ambition X MRI Systems: Mechanical Defect in Hoisting Blocks
Philips has recalled 156 Ingenia Ambition X MRI systems due to a mechanical defect in the hoisting blocks used to move the magnet during decommissioning or relocation. The defect poses a risk that the magnet could fall.
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 is a Class II FDA recall of medical imaging equipment with a mechanical defect in structural hoisting components that could result in equipment dropping. No injuries or hospitalizations have been reported, placing this at the High severity level per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 156 Ingenia Ambition X diagnostic MRI systems (Model Numbers 781356 and 782109) due to a mechanical defect detected in the hoisting interface blocks mounted on top of the magnet.
The MR magnet is equipped with four lifting blocks positioned on top, which are used to move the magnets using a lifting crane during decommissioning or relocation activities. A mechanical issue has been detected on these hoisting interface blocks.
The affected systems were distributed domestically in Florida, Georgia, Michigan, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Texas, and Vermont. Additional systems were distributed internationally to countries including 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 and equipment operators with affected MRI systems should contact Philips to arrange inspection and repair of the hoisting interface blocks before moving the equipment.
The recalled product
- Product
- Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
- Manufacturer
- Philips North America Llc
- Affected units
- 156
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 (2)
- 47519
- 47511
Distribution
Part of a larger recall action
This product is one of 2 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.
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