Recall Z-2216-2024— NovaSignal Corp.

Name: FDA recall Z-2216-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-06

Class II · Ongoing

Class II FDA medical device recall by NovaSignal Corp., initiated 2024-05-06. It names one FDA 510(k) clearance: K213279. Product: NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA. Reason: Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction..

Recalling firm: NovaSignal Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-05-06
Firm location: Los Angeles, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K213279 — NovaGuide 2 Intelligent UltrasoundNovasignal Corporation·cleared 2022-03-02

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

NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA

Reason for recall

Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.

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