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Z-1362-2011

ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed Electrosurgery, Centennial, CO...

ConMed Corporation / initiated 2010-12-27 / Terminated / root cause: design
FDA source (opens on fda.gov)

ConMed Electrosurgery began a recall of ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used... on . The reason FDA records is "Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1362-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ConMed Corporation
Product
ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, 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
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall
Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.
Root cause tag
design
FDA root cause
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
119 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.
Product codes and lots
Serial numbers: 09AGU111, 09AGU112, 09AGU113, 09AGU114, 09AGU115, 09AGU116, 08FGU100, 08FGU101, 08FGU102, 08FGU103, 08FGU104, 08FGU105, 08FGU106, 08FGU107, 08FGU108, 08FGU109, 08GGU001, 08GGU002, 08GGU003, 08GGU004, 08GGU005, 08GGU006, 08GGU007, 08GGU008, 08GGU009, 08GGU010, 08GGU011, 08GGU012, 08GGU013, 08GGU014, 08GGU015, 08GGU016, 08GGU017, 08GGU018, 08GGU019, 08GGU020, 08GGU021, 08GGU022, 08GGU023, 08GGU024, 08GGU025, 08GGU026, 08GGU027, 08GGU028, 08KGU071, 08KGU072, 08KGU073, 08KGU074, 08KGU075, 08KGU076, 08KGU077, 08KGU078, 08KGU079, 08KGU080, 08KGU081, 08KGU082, 08KGU083, 08KGU084, 08KGU085, 08KGU086, 08KGU087, 08KGU088, 08KGU089, 08KGU090, 08LGU001, 08LGU002, 08LGU003, 08LGU004, 08LGU005, 08LGU006, 08LGU007, 08LGU008, 08LGU009, 08LGU010, 08LGU011, 08LGU012, 08LGU013, 08LGU014, 08LGU015, 08LGU016, 08LGU017, 08LGU018, 08LGU019, 08LGU020, 09BGU081, 09BGU082, 09BGU083, 09BGU084, 09CGU001, 09CGU002, 09CGU003, 09CGU004, 09CGU005, 09CGU006, 09CGU007, 09CGU008, 09CGU009, 09CGU010, 09CGO090, 09CGU096, 09CGU097, 09CGU098, 09CGU099, 09CGU100, 09CGU101, 09CGU102, 09CGU103, 09CGU104, 09CGU105, 09CGU106, 09CGU107, 09CGU108, 09CGU109, 09CGU110, 09DGU031, 09DGU032, 09DGU033, 09DGU034, 09DGU035.