Recall Z-0463-2023— 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 Upgrade to MR 7700 System, Model Number 782130. 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 Upgrade to MR 7700 System, Model Number 782130
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.