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U.S. Department of Health and Human Services

Class 2 Device Recall MWave

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 Class 2 Device Recall MWavesee related information
Date Initiated by FirmJune 01, 2025
Date PostedNovember 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0366-2027
Recall Event ID 99850
510(K)NumberK233485 
Product Classification Stimulator, muscle, powered - Product Code IPF
ProductZynex Medical M-Wave, Model: 701200
Code Information UDI-DI: 00852670007540. Firmware Version: 4.3
FEI Number 3017936974
Recalling Firm/
Manufacturer		 Altivera Medical Inc.
14800 Grasslands Dr
Englewood CO 80112-7138
For Additional Information ContactRichard Traynor
201-306-5878
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software Design Change
ActionOn 6/1/2025, a notice was sent to patients informing them updated software to help with device performance was available. Patients were asked to return their original devices. On 10/9/2026, recall notices were mailed to customers asking them to do the following: If you still have a device with affected firmware version notify the firm so they can arrange exchange with a new corrected firmware revision 4.3.3 device. Complete and return the Response Form via email to patientoutreach@altiveramedical.com If you have any questions contact the firm at (720) 779-0218.
Quantity in Commerce1238
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IPF
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