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.
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 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
- Affected units
- 156
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Same hazard · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
Similar recalls
- HighPhilips Ingenia Ambition S MRI Patient Support Floor Plate May Be Incorrectly Installed
FDA (Devices) · 2024-04-24
- HighPhilips Ingenia Elition S MRI systems may have incorrectly installed patient support floor plates
FDA (Devices) · 2024-04-24
- ModerateIngenia Ambition S MRI devices recalled for alignment errors
FDA (Devices) · 2025-05-28
- HighPhilips Ingenia Ambition S MRI Systems Recalled for Falling Speaker Hazard
FDA (Devices) · 2019-03-06
- ModeratePhilips Ingenia Elition S MRI System Alignment Error Recall
FDA (Devices) · 2025-05-28
- HighPhilips Ingenia MRI System Patient Support Table Floor Plate Installation Defect
FDA (Devices) · 2024-04-24