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U.S. Department of Health and Human Services

Class 2 Device Recall GN200 Caiman HF generators

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  Class 2 Device Recall GN200 Caiman HF generators see related information
Date Initiated by Firm January 09, 2017
Date Posted February 16, 2017
Recall Status1 Terminated 3 on June 14, 2017
Recall Number Z-1218-2017
Recall Event ID 76210
510(K)Number K151858  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
Code Information Serial # 1229 1897 1898 1900 1909 1911 1929 1930 1932 1934 1938 1993 1997 1998 1999 2000 2029 2030 2031 2032 2037 2038 2039 2040 2041 2042 2045 2046 2047 2048 2049 2050 2051 2052 2168  
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact
800-258-1946
Manufacturer Reason
for Recall		 Generators may have a faulty component which could impact the proper functioning of the device.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Aesculap mailed an Urgent Medical Device Recall Notification letter dated January 9, 2017, to all affected customers. The notification letter advised customers to discontinue use and quarantine the affected unit if found. Customers were asked to complete the enclosed Acknowledgement form, list the serial number in their possession and return via fax at the number that was provided in the notification. For further questions, please call (800) 258-1946.
Quantity in Commerce 24 generators
Distribution USA (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 = GEI and Original Applicant = Aesculap, Inc.
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