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U.S. Department of Health and Human Services

Class 2 Device Recall Dornier

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  Class 2 Device Recall Dornier see related information
Date Initiated by Firm April 01, 2019
Create Date May 21, 2019
Recall Status1 Terminated 3 on April 20, 2020
Recall Number Z-1381-2019
Recall Event ID 82625
510(K)Number K083500  
Product Classification Powered laser surgical instrument - Product Code GEX
Product Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers
Part Number/Description:
K1001291 600 micron single use fiber
K2011824 600 micron single use fiber
K1001293 600 micron single use fiber
K2011826 600 micron 5X reusable fiber
K1008084 600 micron single use fiber
K2011828 400 micron 5X reusable fiber
K1010500 600 micron fibertome fiber
K2012021 600 micron single use fiber
K1015640 AngioSpot Fiber Kit
K2012393 600 micron single use fiber
K2010292 400 micron single use fiber
K2012439 600 micron 5X reusable fiber
K2010667 micron ITT fiber
K2012875 600 micron 3X reusable fiber
K2010710 400 micron single use fiber
K2012879 400 micron 3X reusable fiber
K2011822 400 micron single use fiber
Product Usage: The Dornier Diode Fibers are accessories to the Dornier Medilas D Family Lasers. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse. and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities. The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.
Code Information All lot numbers
Recalling Firm/
Manufacturer		 Dornier Medtech America, Inc.
1155 Roberts Blvd NW
Kennesaw GA 30144-3600
For Additional Information Contact SAME
770-514-6163
Manufacturer Reason
for Recall		 Pin hole package failures compromising sterility of product
FDA Determined
Cause 2		 Package design/selection
Action Dornier MedTech America notified customers by telephone and follow-up by letter sent Certiied Mail on 4-10-19. Accounts advised of problem, health risk and action to take: The customer should immediately quarantine all inventory of Dornier Diode Laser Fibers and return all product to Dornier per the provided instructions. Contact the Dornier Quality Department at 1-800-367-6437
Quantity in Commerce 400 units
Distribution US Nationwide distribution.
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 = GEX and Original Applicant = DORNIER MEDTECH AMERICA, INC.
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