Z-2068-2023Class II

OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm...

Name: Z-2068-2023 OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm...
Creator: NeuroLogica Corporation
Published: 2023-06-06
License: https://open.fda.gov/license/

Samsung HME America, Inc. / initiated 2023-06-06 / Open, Classified / root cause: manufacturing process

FDA source

NeuroLogica Corporation began a recall of 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 on 2023-06-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2068-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-06
Posted: 2023-07-03
Recalling firm: Samsung HME America, Inc.
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
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: manufacturing process
FDA 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 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 [email protected].
Quantity in commerce: 48 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Grand Bahama, India, Italy, Korea, Portugal, Saudi, Scotland, Thailand.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2068-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2068-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03

Product code JAK

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)