Nicolet¿ Elite¿ 5 MHz Vascular Probe — Class II medical device recall Z-2729-2017
Terminated recall by Natus Neurology Inc, reported 2017-07-19, distributed in AK, AL, AR, AZ, CA, CO, CT, FL…. Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise th
| Recall number | Z-2729-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Neurology Inc, Middleton, WI, United States |
| Recall initiated | 2017-06-09 |
| Classified | 2017-07-13 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2020-07-22 |
| Distributed | 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 |
| Countries outside the US | AU, CA, CH, CL, DE, GB, IN, JO, JP, KW, NL, PH, QA, SA, SE, SG, TH |
| Quantity | 2,335 units |
| 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 and 475 more |
| Model numbers | N500, X1L004 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2729-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.