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U.S. Department of Health and Human Services

Class 2 Device Recall Electrosurgical generator.

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  Class 2 Device Recall Electrosurgical generator. see related information
Date Initiated by Firm December 27, 2010
Date Posted February 17, 2011
Recall Status1 Terminated 3 on August 01, 2011
Recall Number Z-1365-2011
Recall Event ID 57544
510(K)Number K052009  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product ConMed System 2450 Electrosurgical Generator, REF 60-2450-230, 230V-240V, ConMed Electrosurgery, Centennial, CO.
A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
Code Information Serial numbers: 05KGU013, 06CGU036, 06CGU001, 06CGU034, 06CGU035,  06CGU037, 06CGU038, 06CGU039, 06CGU040, 06CGU042, 06CGU043,  06CGU044, 06CGU045, 06CGU046, 06CGU047, 06CGU048, 06CGU049,  06CGU050, 06CGU051, 06CGU052, 06CGU053, 06CGU054, 06CGU055,  06CGU056, 06CGU057, 06CGU058, 06CGU059, 06DGU061, 06DGU062,  06DGU063, 06DGU064, 06DGU065, 06DGU066, 06DGU067, 06DGU068,  06DGU069, 06EGU081, 06EGU082, 06EGU083, 06EGU084, 06EGU085,  06EGU086, 06EGU087, 06EGU088, 06EGU089, 06EGU090, 06EGU091,  06EGU092, 06EGU093, 06EGU094, 06EGU095, 06EGU096, 06EGU097,  06EGU098, 06EGU099, 06EGU100, 06FGU081, 06FGU084, 06FGU085,  06FGU086, 06FGU087, 06FGU088, 06FGU089, 06FGU090, 06LGU001,  06LGU002, 06LGU003, 06LGU004, 06LGU005, 06LGU006, 06LGU007,  06LGU010, 06LGU008, 06LGU009, 06MGU026, 06MGU027, 06MGU028,  06MGU029, 06MGU030, 06MGU031, 06MGU032, 06MGU033, 06MGU034,  06MGU035, 07AGU031, 07AGU032, 07AGU033, 07AGU034, 07AGU035,  07AGU036, 07AGU037, 07AGU038, 07AGU039, 07AGU040, 07AGU041,  07AGU042, 07AGU043, 07AGU044, 07AGU045, 07AGU046, 07AGU047,  07AGU048, 07AGU049, 07HGU052, 07FGU071, 07FGU072, 07FGU073,  07FGU074, 07FGU075, 07FGU076, 07FGU077, 07FGU078, 07FGU079,  07FGU080, 07GGU001, 07GGU002, 07GGU003, 07GGU004, 07GGU005,  07GGU006, 07GGU007, 07GGU008, 07GGU009, 07GGU010, 07HGU051,  07HGU053, 07HGU054, 07HGU055, 07HGU056, 07HGU057, 07HGU058,  07HGU059, 07HGU060, 07HGU061, 07HGU062, 07HGU063, 07HGU064,  07HGU065, 07HGU066, 07HGU067, 07HGU068, 07HGU069, 07HGU070,  07HGU071, 07HGU073, 07JGU051, 07JGU052, 07JGU053, 07JGU054,  07JGU055, 07JGU056, 07JGU057, 07KGU021, 07KGU022, 07KGU023,  07KGU024, 07KGU025, 07KGU026, 07KGU027, 07KGU028, 07KGU029,  07KGU030, 07KGU031, 07KGU032, 07KGU033, 07KGU034, 07KGU035,  07KGU036, 07KGU037, 07KGU038, 07KGU039, 07LGU011, 07LGU012,  07LGU013, 07LGU014, 07LGU015, 07LGU016, 07LGU017, 07LGU018,  07LGU019, 07LGU020, 07MGU021, 07MGU022, 07MGU023, 07MGU024,  07MGU025, 07MGU026, 07MGU028, 07MGU029, 07MGU030, 08AGU051,  08AGU052, 08AGU053, 08AGU054, 08AGU055, 08AGU056, 08AGU057,  08AGU058, 08AGU059, 08AGU060, 08BGU001, 08BGU002, 08BGU003,  08BGU004, 08BGU005, 08BGU006, 08BGU007, 08BGU008, 08BGU009,  08BGU010, 08BGU011, 08BGU012, 08BGU013, 08BGU014, 08BGU015,  08CGU046, 08CGU047, 08CGU048, 08CGU049, 08CGU050, 08CGU051,  08CGU052, 08CGU053, 08CGU054, 08CGU055, 08CGU056, 08CGU057,  08CGU058, 08CGU059, 08CGU060, 08CGU091, 08CGU092, 08CGU093,  08CGU094, 08CGU095, 08CGU096, 08CGU097, 08CGU098, 08CGU099,  08DGU061, 08DGU062, 08DGU063, 08DGU064, 08DGU065, 08DGU066,  08DGU067, 08DGU068, 08DGU069, 08DGU070, 08DGU071, 08DGU072,  08DGU073, 08DGU074, 08DGU075, 08DGU076, 08DGU077, 08DGU078,  08EGU071, 08EGU072, 08EGU073, 08FGU062, 08FGU063, 08FGU064,  08FGU065, 08FGU066, 08FGU067, 08FGU069, 08FGU070, 08FGU071,  08FGU072, 08FGU073, 08FGU074, 08FGU075, 08FGU076, 08FGU077,  08FGU078, 08FGU079, 08FGU080, 08GGU091, 08GGU092, 08GGU093,  08GGU094, 08GGU095, 08GGU096, 08GGU097, 08GGU098, 08GGU099,  08GGU100, 08HGU061, 08HGU062, 08HGU063, 08HGU064, 08HGU065,  08HGU066, 08HGU067, 08HGU068, 08HGU069, 08HGU070, 08HGU071,  08HGU072, 08JGU061, 08JGU062, 08JGU063, 08JGU064, 08JGU065,  08KGU061, 08KGU062, 08KGU063, 08KGU064, 08KGU065, 08KGU066,  08KGU067, 08KGU068, 08KGU069, 08KGU070, 09KGU072, 08KGU091,  08KGU092, 08KGU093, 08KGU094, 08KGU095, 08KGU096, 08KGU097,  08KGU098, 08KGU099, 08KGU100, 08MGU061, 08MGU062, 08MGU063,  08MGU064, 08MGU065, 08MGU066, 08MGU067, 08MGU068, 08MGU069,  08MGU070, 08MGU071, 08MGU072, 08MGU073, 08MGU074, 08MGU075,  09AGU061, 09AGU062, 09AGU063, 09AGU064, 09AGU065, 09AGU066,  09AGU067, 09AGU068, 09AGU069, 09AGU071, 09AGU072, 09AGU074,  09AGU075, 09AGU076, 09AGU73, 09BGU061, 09BGU062, 09BGU063,  09BGU064, 09BGU065, 09CGU076, 09CGU077, 09CGU078, 09CGU079,  09CGU080, 09CGU081, 09CGU082, 09CGU083, 09CGU084, 09CGU085,  09CGU086, 09CGU087, 09CGU088, 09CGU089, 09CGU090, 09CGU091,  09CGU092, 09CGU093, 09CGU094, 09CGU095, 09CGU111, 09CGU112,  09CGU113, 09CGU114, 09DGU061, 09DGU062, 09DGU063, 09DGU064,  09DGU066, 09DGU067, 09DGU068, 09DGU069, 09DGU070, 09DGU071,  09DGU072, 09DGU073, 09DGU074, 09DGU075, 09DGU076, 09DGU077,  09DGU078, 09DGU079, 09DGU080, 09DGU101, 09DGU102, 09DGU103,  09DGU104, 09GGU084, 09GGU081, 09GGU083, 09GGU085, 09GGU086,  09GGU087, 09GGU088, 09GGU089, 09GGU090, 09GGU091, 09GGU092, 09GGU093, 09GGU094, 09GGU095, 09GGU096, 09GGU097, 09GGU098,  09GGU100, 09GGU102, 09GGU103, 09GGU104, 09GGU105, 09GGU106,  09GGU107, 09GGU108, 09GGU109, 09GGU110, 09GGU111, 09GGU112,  09GGU113, 09GGU114, 09GGU115, 09GGU116, 09GGU117. 
Recalling Firm/
Manufacturer		 ConMed Electrosurgery
14603 E Fremont Ave
Centennial CO 80112-4251
For Additional Information Contact
303-269-8294
Manufacturer Reason
for Recall		 Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.
FDA Determined
Cause 2		 Device Design
Action ConMed Electrosurgery sent an Urgent Device Recall letter dted December 27, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify anyone who may have received the affected product.. They were to review their inventory and return a Business Reply Form via fax to 303-699-9854 and to contact ConMed Electrosurgery Technical Services at 800-552-0138 to schedule a time to have their equipment upgraded.
Quantity in Commerce 442 units
Distribution Worldwide Distribution, including USA (nationwide) and the countries of Australia, Belgium, Bolivia, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Honduras, Hong Kong, Hungary, India, Iraq, Israel, Italy, Jamaica, Japan, Jordan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, Vietnam.
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 = GEI and Original Applicant = CONMED CORPORATION
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