FDA Device recall Z-1848-2024
Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
- FDA Device
- Class II
- ongoing
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class II recall of Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device by Philips North America, citing 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, resultin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1848-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-03 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
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
Reason
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
Identifiers
| code_info | UDI-DI: (1) 782103 (01)00884838098299(21); (2) 781377 (01)00884838009813(21); (3) 781342 (01)00884838055339(21) Seria…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 717 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1848-2024%22
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