Recall Z-2395-2023— Philips North America
Class II · Ongoing
Class II FDA medical device recall by Philips North America, initiated 2023-06-12. It names 5 FDA 510(k) clearances: K213516, K193215, K183063 and 2 more. Product: Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X). Reason: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system..
- Recalling firm
- Philips North America
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-12
- 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
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Reason for recall
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.