Philips North America Llc Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
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According to the U.S. Food and Drug Administration (FDA)
Product
Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
Brand
Philips North America Llc
Lot Codes / Batch Numbers
UDI-DI: (1) 782103 (01)00884838098299(21), (2) 781377 (01)00884838009813(21)
Products Sold
UDI-DI: (1) 782103 (01)00884838098299(21); (2) 781377 (01)00884838009813(21); (3) 781342 (01)00884838055339(21) Serial Numbers: Serial Number 85106 71011 71152 71403 71433 71526 71710 71812 71817 71101 71168 71178 71179 71214 71252 71309 71313 71328 71342 71419 71453 71550 71551 71555 71557 71674 71693 71733 71859 71949 71993 71994 85036 85045 85155 71266 71311 71345 71392 71395 71628 71723 85393 71216 71651 85208 71163 71408 71493 71499 71541 71668 71729 71771 71602 71260 71276 71324 71800 71726 71068 71081 71300 71482 71481 71339 71730 71452 71464 71465 71467 71468 71470 71471 71472 71473 71479 71480 71492 71497 71505 71506 71509 71511 71514 71516 71517 71519 71520 71544 71548 71553 71554 71559 71560 71567 71588 71594 71596 71601 71605 71609 71610 71614 71621 71622 71624 71626 71629 71631 71633 71637 71642 71653 71654 71656 71685 71687 71690 71692 71695 71698 71699 71702 71707 71708 71709 71713 71714 71716 71734 71738 71742 71744 71745 71755 71765 71775 71779 71782 71783 71784 71786 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Philips North America Llc is recalling Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a 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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