Z-2772-2020Class II

OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before...

Name: Z-2772-2020 OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before...
Creator: NeuroLogica Corporation
Published: 2020-07-15
License: https://open.fda.gov/license/

Samsung HME America, Inc. / initiated 2020-07-15 / Terminated / root cause: design

FDA source

NeuroLogica Corporation began a recall of 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... on 2020-07-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2772-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-15
Posted: 2020-08-07
Terminated: 2021-07-13
Recalling firm: Samsung HME America, Inc.
Product: 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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: design
FDA 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 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.
Quantity in commerce: 35
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, UK.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2772-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2772-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-07

Product code JAK

K171183Class IIOmniTomNeurologica Corporation / cleared 2017-08-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)