FDA (Devices) recall action 83271
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.
Potential for a transducer mis-alignment in certain transvaginal probes.
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.
GE Healthcare is recalling three refurbished RIC5-9-D ultrasound probes due to a potential transducer misalignment hazard.
GE Healthcare is recalling two ultrasound systems because transvaginal probes may be misaligned. The devices were distributed in the US and internationally.