Recall Z-2210-2025— Philips North America
Class II · Ongoing
Class II FDA medical device recall by Philips North America, initiated 2025-06-30. It names 2 FDA 510(k) clearances: K230972, K193215. Product: Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);. Reason: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire..
- Recalling firm
- Philips North America
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-30
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K230972 — Ingenia Elition and MR 7700 MR Systems
- K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Reason for recall
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Data sourced from openFDA. This site is unofficial and independent of the FDA.