Recall Z-0170-2020 ยท GWJ Stimulator, Auditory, Evoked Response
GN Otometrics
The ICS CHARTR EP 200
| Date | May 28, 2019 |
| Status | Terminated |
| Reason | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 3071 individual units |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cot |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083399 | ICS CHARTR EP 200 Gn Otometrics A/S, Feb 20, 2009 |