OmniTom Computed tomography x-ray system — Class II medical device recall Z-2772-2020
Terminated recall by NeuroLogica Corporation, reported 2020-08-19, distributed nationwide. There are potential issues related to the operational state of the scanner, specifically for transport and ina
| Recall number | Z-2772-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuroLogica Corporation, Danvers, MA, United States |
| Recall initiated | 2020-07-15 |
| Classified | 2020-08-07 |
| Reported by FDA | 2020-08-19 |
| Terminated | 2021-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, IN, PT, SG, TH, TR |
| Quantity | 35 |
| UPC / GTIN / UDI-DI | 08806167789220 |
| Serial numbers | 00007, 00008, 00009, 00010, 00011, 00012, 00013, 00014, 00016, 00017, 00018, 00020, 00021, 00022, 00023, 00024, 00027, 00028, 00030, 00031, 00032, 00033, 00034, 00035, 00036 and 10 more |
| Model numbers | NL5000 |
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.
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.
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-2772-2020. 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.