Recall Z-1049-2023— NovaSignal Corp.

Name: FDA recall Z-1049-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-16

Class II · Ongoing

Class II FDA medical device recall by NovaSignal Corp., initiated 2022-12-16. It names one FDA 510(k) clearance: K160442. Product: Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System. Reason: Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable state but eventually the system will be rendered inoperable..

Recalling firm: NovaSignal Corp.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-16
Firm location: Los Angeles, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K160442 — Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz TransducersNeural Analytics, Inc.·cleared 2016-10-21

K-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

Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System

Reason for recall

Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable state but eventually the system will be rendered inoperable.

Data sourced from openFDA. This site is unofficial and independent of the FDA.