OmniTom Computed tomography x-ray system, Model NL5000, all… recallZ-2772-2020 · NeuroLogica Corporation · initiated Jul 15, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from NeuroLogica Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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 effectiveness of the corrective action. The system label is located near the main input plug or on the side of the system. NeuroLogica will undertake the voluntary corrective action considering the possibility of delay in patient treatment if the scanner is not operational. The hardware and software 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. All corrections in the field will be completed by December 31, 2020. If you need any further information or have any concerns with this issue, then please contact your local representative. Customer Reply Form This reply form is to confirm receipt of the enclosed NeuroLogica Medical Device Field Safety Notice [FSN-NL5000_071620] regarding the potential issues related to the operational state of the scanner and the required software and hardware upgrades. Please read the Notice and indicate the appropriate answers to the questions below.
Recall details
- Recall number
- Z-2772-2020
- Status
- Terminated
- Initiated by the company
- Jul 15, 2020
- Recalling firm
- NeuroLogica Corporation
- Quantity
- 35
- Product code
- JAK
- FDA submissions
- K171183
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, UK.
Product description
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.
Code information (models, lots, serial numbers)
UDI: 08806167789220; all NL5000 systems with software version before 05.01.01; Serial Numbers: 00008 00009 00010 00011 00012 00013 00016 00018 00020 00021 00022 00023 00024 00027 00030 00031 00032 00033 00035 00036 00037 00040 00043 00044 00045 00046 00007 00014 00017 00028 00034 00038 00039 00041 00042
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HS70A Diagnostic Ultrasound System USS-HS7AL4L/WWSamsung Medison CO., Ltd. · Transducer, Ultrasonic, Diagnostic2 recalls0 reports
Other devices under the same FDA submission
1 device cleared under K171183 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CT SCANNER, NL5000 0-NL5000-001Neurologica Corp. · System, X-Ray, Tomography, Computed1 recall12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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