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Open, Classified

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

FDA Recall Z-0715-2024 · Posted 2024-01-11

Recalling FirmPhilips North America
Recall StatusOpen, Classified
Product CodeLNI
Date Initiated2021-07-15
Product Quantity56 US; 169 ROW

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.)

Firm Action

Starting in July 2021, Philips Field Service Engineers (FSE) visited impacted customer sites to inspect the affected systems and turn on the circuit breaker of the extended battery of the UPS where required. All impacted systems were addressed as of February 9, 2023. Instructions for manufacturing and installation were updated on October 31, 2020, which included more detailed instructions for the correct setting of the circuit breaker.

Root Cause

Process change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K213583Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2022-05-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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