Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-2737-2018

May 18, 2018

Class II

Product summary

Firm
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Event
Event 80265
Status
Terminated
Classification
Class II
Quantity
797 Total
Official record key
device-enforcement:Z-2737-2018

Official wording

Reason: Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may cause the cart s video pole to fail.

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.

Distribution pattern: 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, 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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing defect