Oakville, N/A, Canada
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls
6 recalls recorded since 2018, most recently on 18 June 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)2
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 June 2025
- Reason
- Natus received two complaints of left side labeling show impedance for right side.
- Distribution
- US: CA, IN, MO, NC, PA, RI, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2138-2025
- Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Ongoing Class II Medical devices
- Recall started
- 7 May 2025
- Reason
- Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
- Distribution
- Worldwide distribution - US Nationwide including Puerto Rico (PR) and OUS (foreign) countries of: Italy (IT), Estonia (EE), Israel (IL), China (CN), Germany (DE), Saudi Arabia (SA), Switzerland (CH), Chile (CL), Colombia (CO), Netherlands (the) (NL), Japan (JP), United Kingdom of Great Britain and N
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1925-2025
- Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Descripti
Terminated Class II Medical devices
- Recall started
- 2 December 2021
- Terminated
- 18 September 2024
- Reason
- Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, IL, TX, MI, MA, NE, OK, WV, MO, VA, CT, IN, HI, PA, CA, MD, OH, CO, SC, PR, NV, NJ, OR, LA, DC, NC and the countries of Nepal, Viet Nam, Canada, Saudi Arabia, Indonesia, Germany, Korea, Republic of
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0661-2022
- IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Terminated Class II Medical devices
- Recall started
- 5 March 2020
- Terminated
- 9 August 2021
- Reason
- The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality of the affected items.
- Distribution
- Worldwide distribution. US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1630-2020
- natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Terminated Class II Medical devices
- Recall started
- 18 May 2018
- Terminated
- 4 August 2020
- Reason
- Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may cause the cart s video pole to fail.
- 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, F
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2737-2018
- 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 do
Terminated Class II Medical devices
- Recall started
- 15 May 2018
- Terminated
- 6 May 2024
- Reason
- Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plastic case may start melting.
- Distribution
- USA Distribution: AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, ,RI, SC, TN, TX, UT, VA, WA, WI. World wide Distribution: Canada, China, Cyprus, Germany, Hong Kong, Italy, Mexico, Saudi Arabia, Spain, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2570-2018
- XLTEK EMU40EX EEG Headbox
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.