Philips North America Llc Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781358 Recall
Severity assessment pending.
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According to the U.S. Food and Drug Administration (FDA)
Product
Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781358
Brand
Philips North America Llc
Lot Codes / Batch Numbers
UDI-DI: (01)00884838088115(21) Serial Number: 45030
Products Sold
UDI-DI: (01)00884838088115(21) Serial Number: 45030
Philips North America Llc is recalling Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use due to The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospit. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Recommended Action
Per FDA guidance
Philips issued Urgent Medical Device Correction notifications to customers on 22-Apr-2024 via FedEx . Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: If a smoke/fire alarm is detected: a. Immediately stop scanning and evacuate the patient and staff from the examination room. b. If a developing fire is detected, adhere to established hospital fire emergency procedures, which may include switching off power to the complete system and/or removing the magnet field by using the Emergency Magnet Off button. c. Do not attempt to continue scanning. d. Immediately contact Philips Service. " Ensure all users are aware of facility specific Emergency Procedures as outlined in Chapter 2: Safety in the Instructions for Use Emergency procedures The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. " Post this notice near the affected MR system(s) for ease of reference. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt via email to: pd.cnr@philips.com. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 5. The actions planned by Philips to correct the problem Philips will contact you to schedule time for a Field Service Engineer (FSE) to visit your site to inspect the g-MDU connections in the technical room and apply the proper torque to the connection if necessary.(reference FCO78100582). Philips plans t
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This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
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