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U.S. Department of Health and Human Services

Class 2 Device Recall Elite 2

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  Class 2 Device Recall Elite 2 see related information
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  
Product Classification Monitor, ultrasonic, nonfetal - Product Code JAF
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
For Additional Information Contact Janessa Boone
608-829-8603
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.
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
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.
510(K) Database 510(K)s with Product Code = JAF and Original Applicant = NICOLET BIOMEDICAL
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