Recall Z-0459-2023— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2022-11-22. It names 5 FDA 510(k) clearances: K213516, K193215, K183063 and 2 more. Product: Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137. Reason: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-22
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
5 on FDA's record- K213516 — Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei
- K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
- K183063 — Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
- K173451 — Ingenia Elition S and Ingenia Elition X
- K173356 — Ingenia Elition S and Ingenia Elition X R5.4
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
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Reason for recall
Gradient Coil 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.