Natus Neurology Recalls ErgoJust Video Carts Due to Pole Failure Risk
Natus Neurology is recalling 797 ErgoJust mobile video carts because a manufacturing defect may cause the video pole to fail.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Natus Neurology, doing business as Excel Tech., Ltd. (XLTEK), is recalling 797 ErgoJust mobile carts used for mobile medical record documentation. The affected units are labeled as ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, or EuroJust ICU Cart Export For PTZ Video Ext. The recall includes catalog numbers IP-EC-DT-CART, IP-EC-DT-CART-EXP, and part number 021240, covering all units shipped on or before March 12, 2018.
The recall was initiated due to a possible manufacturing defect that may cause the cart's video pole to fail. The agency has classified this as a Class II recall. The affected products were distributed across numerous U.S. states and internationally to countries including Austria, Canada, Germany, and Japan.
Healthcare facilities and consumers should stop using the affected carts and contact Natus Neurology for instructions on how to proceed with the recall.
The recalled product
- 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.
- Manufacturer
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Hazard
- Affected units
- 797
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog/Part Numbers: IP-EC-DT-CART
- IP-EC- DT-CART-EXP
Distribution
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