Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect

FDA device recall Z-0121-2016 · posted 2015-10-15 · Terminated

Recall details

Recalling firm

DJO, LLC

Reason for recall

Overheating and burning of the wire insulation inside the applicator.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

IMJ

Quantity affected

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 an

Date initiated

2015-08-21

Date posted

2015-10-15

Date terminated

2016-10-24

Location

Vista, CA

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