Recall Z-2398-2023— 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: During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock 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
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.