GN Otometrics Horskatten 9 Taastrup Denmark The ICS CHARTR EP 200 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.

Recommended Action

Per FDA guidance

On May 2019 Otometrics a division of Natus sent letter to the consignees with the following instructions: General Information FSN Type: Recall Natus will be removing all affected products from the market. Further information or advice While there have not been any reported safety incidences, our commitment to providing only the highest quality products and information to our customers and distribution partners is our top priority, and we sincerely apologize for any inconvenience this will cause. If there are any questions about this notice, please contact your authorized Natus distributor. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. (As appropriate) Please transfer this notice to other organizations on which this action has an impact. (As appropriate) Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Please report all device-related incidents to the manufacturer, distributor or local representative, and the national Competent Authority if appropriate, as this provides important feedback EU customers only: The Competent (Regulatory) Authority of your country has been informed about this communication to customers. Attached Instructions for device return Customer Reply Form List of affected part numbers INSTRUCTIONS FOR DEVICE RETURN We kindly ask that you initiate the following activities immediately: 1. Identify and quarantine the affected devices. Cease use of all affected devices immediately. 2. Review this communication in its entirety and ensure that all users of the listed products in your organization are informed of this notification. 3. Distribute this notification to all associated parties within your organization. 4. Complete and return the Verification Form enclosed in this letter via e-mail o

Distribution

As reported by FDA

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, DC, PR