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

FDA device recall Z-2216-2024 · posted 2024-06-27 · Open, Classified

Recall details

Recalling firm

NovaSignal Corp.

Reason for recall

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

Action taken

On May 6, 2024, NeuraSignal Inc. dba NovaSignal issued a "Urgent-Medical Device Recall" notification to affected consignees. Nova Signal asked consignees to take the following actions: 1. The NeuraSignal service and customer support team will schedule a time for the onsite field correction. 2. In the timeframe leading up to the scheduled onsite field correction, the system can be used as intended. 2a. Users of the device should refrain from accessing the enclosed cable connections during routine operation. This may lead to unintentional disconnection of the chassis ground cable from the AC mains power distribution unit. It is recommended that the cart compartment remains locked while the device is commissioned for use. 3. The site should confirm that the grounding cable has not been unintentionally disconnected and maintains a secure connection to the power distribution unit 4. If necessary, resources from the Biomedical Equipment department may perform re-qualification or pre-installation qualification testing, to ensure the system is adequately grounded.

Root cause

Device Design

Status

Open, Classified

Product code

IYN

Quantity affected

45 systems

Distribution

Worldwide - US Nationwide distribution in the states of MA, TX, NY, MN, AZ, AL, CO, CA, OH, MO, FL, TN, NJ, GA, OK, KY, WA and the country of Canada.

Date initiated

2024-05-06

Date posted

2024-06-27

Location

Los Angeles, CA

Related 510(k) clearances