FDA Device recall Z-2728-2017
Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300
- FDA Device
- Class II
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class II recall of Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300 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-2728-2017 |
| 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¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. 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: CAQ0100 CAQ0101 CAQ0102 CAQ0103 CAQ0104 CAQ0105 CAQ0106 CAQ0107 CAQ0108 CAQ0109 CAQ0110 CAQ0…Serial numbers: CAQ0100 CAQ0101 CAQ0102 CAQ0103 CAQ0104 CAQ0105 CAQ0106 CAQ0107 CAQ0108 CAQ0109 CAQ0110 CAQ0111 CAQ0112 CAQ0113 CAQ0114 CAQ0115 CAQ0116 CAQ0117 CAQ0118 CAQ0119 CAQ0120 CAQ0121 CAQ0122 CAQ0123 CAQ0124 CAQ0125 CAQ0126 CAQ0127 CAQ0128 CAQ0129 CAQ0130 CAQ0131 CAQ0132 CAQ0133 CAQ0134 CAQ0135 CAQ0136 CAQ0137 CAQ0138 CAQ0139 CAQ0140 CAQ0141 CAQ0142 CAQ0143 CAQ0144 CAQ0145 CAQ0146 CAQ0147 CAQ0148 CAQ0149 CAQ0150 CAQ0151 CAQ0152 CAQ0153 CAQ0154 CAQ0155 CAQ0156 CAQ0157 CAQ0158 CAQ0159 CAQ0160 CAQ0161 CAQ0162 CAQ0163 CAQ0164 CAQ0165 CAQ0166 CAQ0167 CAQ0168 CAQ0169 CAQ0170 CAQ0171 CAQ0172 CAQ0173 CAQ0174 CAQ0175 CAQ0176 CAQ0177 CAQ0178 CAQ0179 CAQ0180 CAQ0181 CAQ0182 CAQ0183 CAQ0184 CAQ0185 CAQ0186 CAQ0187 CAQ0188 CAQ0189 CAQ0190 CAQ0191 CAQ0192 CAQ0193 CAQ0194 CAQ0195 CAQ0196 CAQ0197 CAQ0198 CAQ0199 CAQ0200 CAQ0201 CAQ0202 CAQ0203 CAQ0204 CAQ0205 CAQ0206 CAQ0207 CAQ0208 CAQ |
|---|
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-2728-2017%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.