Product Wiki · Recalls · U.S. FDA — Device Enforcement

Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X) — recall Z-2398-2023

U.S. FDA — Device Enforcement · United States · 2023-06-12 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2398-2023
Date of alert
2023-06-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838088115
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.