OmniTom/OmniTom Elite- X-ray computed tomography applications for… — Class II medical device recall Z-2068-2023
Ongoing recall by NeuroLogica Corporation, reported 2023-07-12, distributed nationwide. 1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the devi
| Recall number | Z-2068-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuroLogica Corporation, Danvers, MA, United States |
| Recall initiated | 2023-06-06 |
| Classified | 2023-07-03 |
| Reported by FDA | 2023-07-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, GB, IN, IT, KR, PT, TH |
| Quantity | 48 units |
| UPC / GTIN / UDI-DI | 10815411020335, 10815411020663 |
| Serial numbers | 15R |
| Model numbers | NL5000 |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2068-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.