Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2737-2018Class II

Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD...

Natus Medical Incorporated / initiated 2018-05-18 / Terminated / root cause: manufacturing process

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) began a recall of 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... on . FDA classified it as Class II and gives the reason as "Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may cause the cart s video pole to fail". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2737-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Natus Medical Incorporated
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.
Product code
ODI Administration Set Docking Station
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.
Root cause tag
manufacturing process
FDA 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 [email protected].
Quantity in commerce
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, 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
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2737-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2737-2018Class IITerminatedVoluntary: Firm initiated