Recall Z-2737-2018 ยท ODI Administration Set Docking Station
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.
| Date | May 18, 2018 |
| Status | Terminated |
| Reason | Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may cause the cart s video pole to fail. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Natus Neurology, notified its customers on approximately 05/18/2018 via an "URGENT: Medical Device Correction Notification" letter. Natus Neuro Technical Service will contact customers regarding sending this kit to their bio-medical engineering department. Kits are expected to be available the first week of June. If you have any questions regarding this correction, please contact our Technical Support Administrator by email at ErgojustFCA@natus.com. |
| Quantity | 797 Total |
| Distribution | United States Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV. Worldwide Distribution: Austria, Canada, Colombia, Costa Rica, Czech Republic, Fra |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.