Recall Z-2728-2017 ยท JAF Monitor, Ultrasonic, Nonfetal
Natus Neurology Inc
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.
| Date | Jun 9, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Customer notification via an Urgent Recall Notification/Field Notice began 06/09/2017. The letter identified the affected product and the reason for the recall. Customers were asked to complete and return the attached verification form. The firm will replace functioning probes that returned free of charge. Customers are to follow the instructions provided for returning any affected devices. |
| Quantity | 2,335 units total |
| Distribution | Worldwide Distribution -- US, to the following states: 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, and WV and, to the countries of Australia, Canada, Chile, Columbia, Germ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982635 | CAREDOP II Nicolet Biomedical, Aug 7, 1998 |