Reported Aug 19, 2020 · Terminated
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 -…
NeuroLogica Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NeuroLogica Corporation · 14 Electronics Ave · Danvers, MA · 01923-1011
Is this the product you have?
- OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 -
- Product Usageis 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
- Lot codes and dates
- UDI08806167789220; all NL5000 systems with software version before 05.01.01
- Serial Numbers
0000800009000100001100012000130001600018000200002100022000230002400027000300003100032000330003500036000370004000043000440004500046000070001400017000280003400038000390004100042
- Amount recalled
- 35
Where it was sold
- Nationwide
Why it 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.
This product could cause temporary or reversible health problems — stop using it.
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