The FDA announced on April 23, 2021, that Philips North America LLC is recalling Ingenia Ambition X diagnostic MR systems due to a mechanical issue with hoisting interface blocks. The agency issued recall number Z-1795-2021 for the voluntary Class II action.
How to tell if you have it
- Brand: Philips
- Product: Ingenia Ambition X Diagnostic MR system
- Model Numbers: 781356, 782109
- REF 781356/UDI-DI 00884838090040 Serial Numbers: 47001, 47002, 47003, 47009, 47000, 47012, 47017, 47013, 47047, 47040, 47052, 47015, 47049, 47056, 47023, 47019, 47030, 47053, 47014, 47035, 47034, 47020, 47048, 47080, 47032, 47057, 47041, 47072, 47075, 47091, 47219, 47184, 47058, 47258, 47215, 47197, 47004, 47026, 47006, 47007, 47018, 47027, 47011, 47037, 47039, 47029, 47038, 47043, 47022, 47044, 47070, 47062, 47071, 47054
- REF 781356/UDI-DI 00884838090040 Serial Numbers (added November 2023): 47016, 47045, 47059, 47067, 47065, 47082, 47089, 47033, 47244, 47085, 47025, 47060, 47024, 47063, 47061, 47051, 47096, 47097, 47028, 47094, 47225, 47064, 47248, 47074, 47083, 47187, 47098, 47174, 47068, 47190, 47195, 47227, 47194, 47245, 47175, 47221, 47226, 47088, 47220, 47270, 47050, 47084, 47099, 47093, 47203, 47275, 47260, 47264, 47252
- REF 782109/UDI-DI 00884838098350 Serial Numbers: 47500, 47519, 47511
- Units affected: 156 MR Systems
The hazard
The MR magnet is equipped with four lifting blocks positioned on top of the magnet to allow movement by a lifting crane. A mechanical issue was detected on these hoisting interface blocks, which are used during decommissioning or moving activities.
Context
GovInfoNow's records show Philips North America LLC has issued 129 other recalls since July 12, 2017. Recent recalls include the SmartPath to dStream systems recall on August 21, 2026, and the Spectral CT 7500 Scanner recall on August 18, 2026. Other recent recalls of similar products include the Philips Ingenia Elition X MRI Systems Recall (December 3, 2025), the Philips Ingenia Elition S MRI Systems Recall (December 3, 2025), and the Philips Ingenia Ambition X MRI Systems Recall (December 3, 2025).