Reported Mar 30, 2016 · Terminated
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
QiG Group LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: QiG Group LLC · 10675 Naples St NE · Blaine, MN · 55449-5802
Is this the product you have?
- Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
- Lot codes and dates
- Serial Numbers
03EDBF03EDC103EDC503EDC703EDC903EDCA03EDCE03EDD003EDE503EDE803EDE903EDEA03EDEF03EDF003EE0103EE0303EE0503EE1C03EE1F03EE2403EE2503EE2603EE2803EE3403EE3503EE3603EE3703EE3A03EE3B03EE5A03EE5B03EE6003EE9603EE9703EE9803EE9D03EE9F03EEA203EEA303EEA403EEAC
- Serial Numbers
- Amount recalled
- 40
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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