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Class 2 Device Recall Elite 2 |
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Date Initiated by Firm |
June 09, 2017 |
Create Date |
July 13, 2017 |
Recall Status1 |
Terminated 3 on July 22, 2020 |
Recall Number |
Z-2727-2017 |
Recall Event ID |
77569 |
510(K)Number |
K982635
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Product Classification |
Monitor, ultrasonic, nonfetal - Product Code JAF
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Product |
Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20.
Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. |
Code Information |
Serial numbers: CHR0140 CHR0141 CHR0142 CHR0143 CHR0144 CHR0145 CHR0146 CHR0147 CHR0148 CHR0149 CHR0150 CHR0151 CHR0152 CHR0153 CHR0154 CHR0155 CHR0156 CHR0157 CHR0158 CHR0159 CHR0160, and CHR0161. |
Recalling Firm/ Manufacturer |
Natus Neurology Inc 3150 Pleasant View Rd Middleton WI 53562-4800
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For Additional Information Contact |
Janessa Boone 608-829-8603
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Manufacturer 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.
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FDA Determined Cause 2 |
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 in Commerce |
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, Germany, India, Japan, Jordan, Kuwait, Netherlands, Papua Guinea, Philippines, Qatar, Saudi Arabia, Singapore, Sweden, Switzerland, Thailand, and United Kingdom. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = JAF and Original Applicant = NICOLET BIOMEDICAL
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