medical Class II Updated 2023-07-12

NeuroLogica Corporation recalls OmniTom/OmniTom Elite- X-ray computed tomography application

Recalled 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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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