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FDAJune 6, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

neurologica

UPCs

1081541102033510815411020663

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear