FDA (Devices) recall action 73150
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm). The following functions may not be available: Reprogramming the stimulator, Adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and Recharging the stimulator.
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.
QiG Group LLC is recalling 34 Algovita Implanted Pulse Generators because they may fail to connect to external devices unless held very close, preventing reprogramming and recharging.
QiG Group LLC is recalling 40 Algovita Implanted Pulse Generators because they may fail to connect to external devices unless held very close.
QiG Group LLC is recalling 31 Algovita External Pulse Generators because they may fail to connect to external devices, preventing reprogramming and recharging.