Recall Z-0121-2016— DJO, LLC

Name: FDA recall Z-0121-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-21

Class II · Terminated

Class II FDA medical device recall by DJO, LLC, initiated 2015-08-21, terminated 2016-10-24. It names one FDA 510(k) clearance: K083433. 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.. Reason: Overheating and burning of the wire insulation inside the applicator..

Recalling firm: DJO, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-08-21
Terminated: 2016-10-24
Firm location: Vista, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K083433 — INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601Chattanooga Group·cleared 2009-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Overheating and burning of the wire insulation inside the applicator.

Data sourced from openFDA. This site is unofficial and independent of the FDA.