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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-2726-2017
Recall Event ID 77569
510(K)Number K982635  
Product Classification Monitor, ultrasonic, nonfetal - Product Code JAF
Product Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200.

Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
Code Information Serial numbers: CER0179 CER0240 CER0241 CER0242 CER0243 CER0244 CER0245 CER0246 CER0247 CER0248 CER0249 CER0250 CER0251 CER0252 CER0253 CER0254 CER0255 CER0256 CER0257 CER0258 CER0259 CER0260 CER0261 CER0262 CER0263 CER0264 CER0265 CER0266 CER0267 CER0268 CER0269 CER0270 CER0271 CER0272 CER0273 CER0274 CER0275 CER0276 CER0277 CER0278 CER0279 CER0280 CER0281 CER0282 CER0283 CER0284 CER0285 CER0286 CER0287 CER0288 CER0289 CER0290 CER0291 CER0292 CER0293 CER0294 CER0295 CER0296 CER0297 CER0298 CER0299 CER0300 CER0301 CER0302 CER0303 CER0304 CER0305 CER0306 CER0307 CER0308 CER0309 CER0310 CER0311 CER0312 CER0313 CER0314 CER0315 CER0316 CER0317 CER0318 CER0319 CER0320, and CER0321. 
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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