FDA (Devices) recall action 94673
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
NovaGuide 2 Traditional Ultrasound systems may have grounding cables that can be inadvertently disconnected during use, creating risk of electrical shock and equipment malfunction. Twenty-eight systems have been distributed nationwide.
FDA is recalling 45 NovaGuide 2 Intelligent Ultrasound systems due to a defective grounding cable that could become disconnected and cause electrical shock, electrical interference, or equipment malfunction.