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U.S. Department of Health and Human Services

Class 2 Device Recall Monode

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  Class 2 Device Recall Monode see related information
Date Initiated by Firm August 21, 2015
Date Posted October 15, 2015
Recall Status1 Terminated 3 on October 24, 2016
Recall Number Z-0121-2016
Recall Event ID 72168
510(K)Number K083433  
Product Classification Diathermy, shortwave, for use in applying therapeutic deep heat - Product Code IMJ
Product Monode, Shortwave Accessory
Model #: 02200002

Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.
Code Information Model #: 02200002  All units received from the manufacture prior to the week of July 12, 2015
Recalling Firm/
Manufacturer		 DJO, LLC
1430 Decision St
Vista CA 92081-8553
For Additional Information Contact
760-727-1280
Manufacturer Reason
for Recall		 Overheating and burning of the wire insulation inside the applicator.
FDA Determined
Cause 2		 Device Design
Action The firm sent out two customer notification letters; one to distributors and one to direct users. Letters were sent September 1, 2015 via USPS certified return receipt. Distributors were asked to obtain a list of their customers with contact information that have purchase or received the monode accessory or Intelect Shortwave device that included the monode as an accessory item. Once the list has been assembled the firm requests that it be forwarded to DJO Global Chattanooga Product Support by phone 877-733-4888, or by e-mail at monode.support@djoglobal.com. The firm's notification states that customers will be sent an upgraded monode accessory along with a pre-paid shipper for the return of the current used unit. Any questions the letter states to contact Product Support per the contact information above or William Fisher, Global Regulatory Compliance at 760-734-3126. Letters sent to direct users received the same instruction of returning the product for a replacement. Any questions the letter states to call 877-733-4888 or email at monode.support@djoglobal.com.
Quantity in Commerce 2887
Distribution Worldwide Distribution - US Nationwide in the states of WY, OH, WA, NC, FL, NE, GA, KS CA, MO, IN, MA, IL, OK, AZ, TX, AR, UT, NJ, WI, PA, SC, WV, NY, MI, MN, VA, AK, TN, OR, NC, NH, KY, CO, NV, ID and the countries of El Salvador, China, Ecuador, South Korea, Chile, Israel, Peru, Nicaragua, Bolivia, Indonesia
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IMJ and Original Applicant = CHATTANOOGA GROUP
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