Recall Z-2068-2023— NeuroLogica Corporation
Class II · Ongoing
Class II FDA medical device recall by NeuroLogica Corporation, initiated 2023-06-06. It names 2 FDA 510(k) clearances: K202526, K171183. 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. Reason: 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.
- Recalling firm
- NeuroLogica Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-06
- Firm location
- Danvers, MA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.