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
Reported: July 12, 2023 Initiated: June 6, 2023 #Z-2068-2023
Product Description
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
Reason for Recall
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
Details
- Recalling Firm
- NeuroLogica Corporation
- Units Affected
- 48 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Grand Bahama, India, Italy, Korea, Portugal, Saudi, Scotland, Thailand.
- Location
- Danvers, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by NeuroLogica Corporation. Units affected: 48 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2023. Severity: Moderate. Recall number: Z-2068-2023.
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