FDA Device recall Z-2398-2023
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
- FDA Device
- Class II
- ongoing
- Published 2023-08-16
On 2023-08-16 the FDA classified a Class II recall of Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X) by Philips North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2398-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-12 |
| Published | 2023-08-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
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.
Identifiers
| code_info | Product Number 781358: UDI-DI: 00884838088115; Serial Numbers: 45481 45476 45473 45470 45469 45467 45464 45463 454614…Product Number 781358: UDI-DI: 00884838088115; Serial Numbers: 45481 45476 45473 45470 45469 45467 45464 45463 4546145459 45456 45451 45450 45448 45447 45446 45444 45443 45442 45441 45439 45438 45437 45435 45434 45432 45429 4542845426 45423 45421 45419 45417 45416 45414 45412 45411 45410 45409 45408 45407 45406 45399 45398 45397 45396 4539545394 45393 45392 45391 45390 45382 45381 45379 45378 45377 45376 45374 45372 45371 45370 45369 45368 45367 4536445363 45362 45360 45359 45357 45356 45355 45354 45353 45352 45350 45349 45348 45345 45344 45343 45342 45340 4533945338 45337 45335 45333 45332 45330 45328 45323 45322 45321 45320 45319 45317 45316 45315 45314 45313 45312 4531145310 45309 45308 45307 45306 45305 45304 45303 45302 45300 45296 45295 45294 45293 45292 45290 45289 45284 4528245281 45280 45279 45278 45277 45276 45274 45272 45269 45268 45267 45265 45264 45263 45262 45261 45260 45259 4525745253 45252 45250 45249 45248 45247 45246 45245 45244 45243 45242 45241 45238 45237 45236 4 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2398-2023%22
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