Medical Device Recall: (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
Philips North America · July 15, 2021
Reason for Recall
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.)
Distribution
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.
States Affected
CA, DE, FL, GA, IL, KY, MA, ME, MI, MO, NH, NJ, NM, NY, OH, PA, SC, TN, TX, VA, VT, WI, WY
Quantity Affected
56 US; 169 ROW
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0715-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.