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U.S. Department of Health and Human Services

Class 2 Device Recall ErgoJust Carts

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 Class 2 Device Recall ErgoJust Cartssee related information
Date Initiated by FirmMay 18, 2018
Create DateAugust 08, 2018
Recall Status1 Terminated 3 on August 04, 2020
Recall NumberZ-2737-2018
Recall Event ID 80265
Product Classification Administration set docking station - Product Code ODI
ProductNatus 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.
Code Information Catalog/Part Numbers: IP-EC-DT-CART; IP-EC- DT-CART-EXP, and part number 021240 which is a variation of IP-EC-DT-CART. All ErgoJust Carts that were shipped on or before 03/12/2018 are affected and included in this recall.
FEI Number 3002809369
Recalling Firm/
Manufacturer		 Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
2568 Bristol Cir
Oakville Canada
For Additional Information Contact
905-287-5055
Manufacturer Reason
for Recall		Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may cause the cart s video pole to fail.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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 in Commerce797 Total
DistributionUnited 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, France, Germany, Hong Kong, Israel, Japan, Jordan, Korea, ,Republic of Latvia, Malaysia, Oman, Philippines, Portugal, Saudi Arabia, Serbia, Slovenia, Switzerland. Sold To Location State 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 Sold To Location State 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 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
Total Product Life CycleTPLC 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.
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