FDA Device recall Z-2729-2017
Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500
- FDA Device
- Class II
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class II recall of Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500 by Natus Neurology, citing some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or bloo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2729-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-09 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Natus Neurology |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV |
Product
Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
Reason
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood flow.
Identifiers
| code_info | Serial numbers: CBQ0302 CBQ0344 CBQ0385 CBQ0386 CBQ0387 CBQ0388 CBQ0389 CBQ0390 CBQ0391 CBQ0392 CBQ0393 CBQ0…Serial numbers: CBQ0302 CBQ0344 CBQ0385 CBQ0386 CBQ0387 CBQ0388 CBQ0389 CBQ0390 CBQ0391 CBQ0392 CBQ0393 CBQ0394 CBQ0395 CBQ0396 CBQ0397 CBQ0398 CBQ0399 CBQ0400 CBQ0401 CBQ0402 CBQ0403 CBQ0404 CBQ0410 CBQ0411 CBQ0412 CBQ0413 CBQ0414 CBQ0415 CBQ0416 CBQ0417 CBQ0418 CBQ0419 CBQ0420 CBQ0421 CBQ0422 CBQ0423 CBQ0424 CBQ0425 CBQ0426 CBQ0427 CBQ0428 CBQ0429 CBQ0430 CBQ0431 CBQ0432 CBQ0433 CBQ0434 CBQ0435 CBQ0436 CBQ0437 CBQ0438 CBQ0439 CBQ0440 CBQ0441 CBQ0442 CBQ0443 CBQ0444 CBQ0445 CBQ0446 CBQ0447 CBQ0448 CBQ0449 CBQ0450 CBQ0451 CBQ0452 CBQ0453 CBQ0454 CBQ0455 CBQ0456 CBQ0457 CBQ0458 CBQ0459 CBQ0460 CBQ0461 CBQ0462 CBQ0463 CBQ0464 CBQ0465 CBQ0466 CBQ0467 CBQ0468 CBQ0469 CBQ0470 CBQ0471 CBQ0472 CBQ0473 CBQ0474 CBQ0475 CBQ0476 CBQ0477 CBQ0478 CBQ0479 CBQ0480 CBQ0481 CBQ0482 CBQ0483 CBQ0484 CBQ0485 CBQ0486 CBQ0487 CBQ0488 CBQ0489 CBQ0490 CBQ0491 CBQ0492 CBQ0493 CBQ0494 CBQ0495 CBQ0496 CBQ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2729-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.