The FDA announced on 2021-07-15 that Philips North America is recalling Ingenia Ambition X and Ingenia Ambition S MRI systems due to a hazard where the sealed magnet may experience an uncontrolled shutdown known as Loss-of-Field (LoF) if cryo-cooling is lost. The FDA said this risk arises from events such as site power outages.
How to tell if you have it
- Philips Ingenia Ambition X, Product Number 781356, UDI-DI 00884838090040, Serial Numbers 47000-47072, 47074-47075, 47077-47078, 47080-47085, 47088-47089, 47091-47099, 47174-47175, 47177, 47183-47184, 47187-47188, 47190, 47192-47199, 47202-47203, 47206, 47208-47209, 47211, 47215-47216, 47219-47221, 47225-47227, 47244-47245, 47247-47248, 47252, 47255, 47258, 47260, 47262, 47268-47269, 47270-47272, 47275-47276, 47279, 47284, 47297-47298, 47282
- Philips Ingenia Ambition S, Product Number 781359, UDI-DI 00884838090057, Serial Numbers 48000-48001, 48003-48005, 48009-48020, 48022-48023, 48026-48028, 48031-48040, 48043-48047, 48049-48053, 48055-48056, 48112, 48120, 48122, 48127-48131, 48133-48134, 48136, 48144, 48148, 48151-48155, 48158, 48160, 48162, 48166-48167, 48169, 48171-48174, 48179-48184, 48186-48188, 48190-48192, 48194, 48196, 48198-48200
The hazard
According to the FDA, the sealed magnet will experience an uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling. This loss of cooling can be caused by events such as a power outage on site.
Context
GovInfoNow's records show Philips North America has had 30 other recalls since 2020-12-24. Other recent recalls include the Philips MR 5300 recall from 2026-08-28, the Philips PIC iX Essentials Software Freeze recall from 2026-07-31, and the Philips Achieva 1.5T MRE Scanner Recall from 2026-04-14. Other recent recalls of similar products include the Philips Achieva 3.0T MRI recall from 2026-08-21, the Philips Brilliance CT 64 Medical Scanner recall from 2026-08-07, and the Philips Ingenuity CT Scanners recall from 2026-08-07.