Myoguide System Model 8008
Intronix Technologies Corporation · Model 8008 · UDI-DI 00627843471783
Description
The Intronix Model 8008 Myoguide system (Myoguide) is a medical device that operates as an electromyography (EMG) amplifier with onboard stimulator and signal display. It is intended for use to amplify muscle signals (EMG) from muscle and provide audio and visual feedback to assist clinicians in locating areas of muscle activity. The stimulator can be used for nerve localization or to invoke a muscle twitch. These features provide feedback used for guidance of injections into muscle or in the vicinity of nerves. This device is a battery powered, handheld, EMG amplifier with audio feedback and stimulator, LCD EMG signal and device status display, and current stimulation ranging from 0 mA - 20 mA.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-17 | B Braun Medical Inc | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 2024-05-17 | B Braun Medical Inc | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 2024-05-17 | B Braun Medical Inc | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 2024-05-17 | B Braun Medical Inc | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. |
| 2010-02-01 | Stryker Instruments Div. of Stryker Corporation | Device may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the effects of the nerve block. |
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