FDA-Device2024-01-17Class II
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
Philips North America
Hazard
The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)
Sold states
Domestic distribution to the following states and territories: CA DE FL GA IL KY MA ME MI MO NH NJ NM NY OH PA SC TN TX VA VT WI WY, and PR. International distribution worldwide.
Affected count
56 US; 169 ROW
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0715-2024Don't want to check this manually?
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