NeuroLogica Corporation OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000
Brand
NeuroLogica Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
GTIN: 10815411020335 10815411020663 Serial Numbers: 10 14 23 25 26 36 38 40 41 42 44 46 48 49 50 51 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 15R
NeuroLogica Corporation is recalling OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the due to 1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient tr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment
Recommended Action
Per FDA guidance
NeuroLogica Corporation issued Urgent Medical Device Correction letter to customers via email June 6, 2023. Letter states reason for recall, health risk and action to take: Users may continue to use the NL5000 system with caution, ensuring they are aware of the potential drive issues due to the wheels. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. NeuroLogica will undertake the voluntary corrective action considering the possibility of delay in patient treatment if the scanner is not operational due to battery failure, as well as the potential for the scanner to halt mid scan. The hardware upgrades provide additional safeguards by improving the design to minimize any risks of the above situations from happening. Service engineers will correct all affected devices free of charge and contact you to arrange for the correction starting June 2023. All corrections in the field will be completed by December 31, 2023. Contact customer service team at 1-888-564-8561 (US/Canada) or 978-564-8561 (International) and support@neurologica.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026