PlainRecalls
FDA Devices Moderate Class II Ongoing

(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)

Reported: January 17, 2024 Initiated: July 15, 2021 #Z-0715-2024

Product Description

(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)

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.)

Details

Recalling Firm
Philips North America
Units Affected
56 US; 169 ROW
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.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359). Recalled by Philips North America. Units affected: 56 US; 169 ROW.
Why was this product recalled?
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.)
Which agency issued this recall?
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0715-2024.