Zynex Medical M-Wave stimulator recalled for possible muscle fatigue
Zynex Medical M-Wave muscle stimulators may deliver constant electrical impulses to all four electrodes at once, instead of alternating between them as designed. This may cause muscle fatigue. The recall covers model 701200 with firmware 4.3 and was distributed nationwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Stop using the affected Zynex Medical M-Wave stimulator.
- Check that your device is model 701200 with UDI-DI 00852670007540 and firmware version 4.3.
- The notice doesn't say how to get a remedy; contact Zynex Medical or the place you bought the device.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Zynex Medical M-Wave, Model: 701200
- Sold in
- Nationwide
- Made for
- Adults (18 years to 100 years)
Details
- Units affected
- 1238
- Illnesses reported
- None reported
- Manufactured in
- 14800 Grasslands Dr, Englewood, Colorado, United States
- Classification
- Class II
- Recall number
- Z-0366-2027
In the FDA's words
- Description
- Zynex Medical M-Wave, Model: 701200 Muscle stimulator may deliver constant electrical impulses to all four electrodes simultaneously, instead of alternating between the electrodes as designed, which may cause muscle fatigue. UDI-DI: 00852670007540. Firmware Version: 4.3 Distribution: US Nationwide distribution including in the states of TX, TN, NJ, OH, IA, SC, WI, GA, MD, FL, PA, CO, NY, OK, CT, AR, KY, KS, CA, AL, DE, LA, VA, NM, NE, MN, IN, MI, MO, DC, WA, UT, IL, ME, RI, MA, WV, NC, NV, MS, HI, OR, ND, AK, AZ, NH, ID, VT. Affected quantity: 1238
- Hazard
- Muscle stimulator may deliver constant electrical impulses to all four electrodes simultaneously, instead of alternating between the electrodes as designed, which may cause muscle fatigue.