Recall record at a glance
| Official record | Z-2737-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Report date | Aug 15, 2018 |
| Recall initiation date | May 18, 2018 |
| Quantity | 797 Total |
| Location | Oakville, N/A, Canada |
Official product description
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.
Why the product was recalled
Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may cause the cart s video pole to fail.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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