Recall record at a glance
| Official record | Z-2772-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | NeuroLogica Corporation |
| Report date | Aug 19, 2020 |
| Recall initiation date | Jul 15, 2020 |
| Quantity | 35 |
| Location | Danvers, MA, United States |
Official 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.
Why the product 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.
Distribution information
Worldwide distribution - US Nationwide distribution and the countries of Canada, India, Portugal, Singapore, Slovak Republic, Thailand, Turkey, UK.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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