Recall Z-2772-2020 ยท JAK System, X-Ray, Tomography, Computed
NeuroLogica Corporation
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
| Date | Jul 15, 2020 |
| Status | Terminated |
| Reason | There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient treatment if proper use instructions are not followed. |
| Root cause | Device Design |
| Action | Urgent Medical Device Correction notification letters were sent to customers beginning 7/15/20. Users may continue to use the NL5000 system if proper instructions for use are followed as described in user manual (1-NL5000-060). 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 effective |
| Quantity | 35 |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171183 | OmniTom Neurologica Corporation, Aug 18, 2017 |