Recall Z-2772-2020— NeuroLogica Corporation
Class II · Terminated
Class II FDA medical device recall by NeuroLogica Corporation, initiated 2020-07-15, terminated 2021-07-13. It names one FDA 510(k) clearance: K171183. Product: OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is 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.. Reason: 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..
- Recalling firm
- NeuroLogica Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-15
- Terminated
- 2021-07-13
- Firm location
- Danvers, MA, United States
510(k) clearances named in this recall
1 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 Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.