Recall Z-2068-2023 ยท JAK System, X-Ray, Tomography, Computed
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
| Date | Jul 3, 2023 (initiated Jun 6, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Process design |
| Action | 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 |
| Quantity | 48 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, Grand Bahama, India, Italy, Korea, Portugal, Saudi, Scotland, Thailand. |
| FDA record | Open on fda.gov |