Recall Z-1218-2017 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Aesculap Implant Systems LLC
GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
| Date | Feb 16, 2017 (initiated Jan 9, 2017) |
| Status | Terminated |
| Reason | Generators may have a faulty component which could impact the proper functioning of the device. |
| Root cause | 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 | 24 generators |
| Distribution | USA (nationwide Distribution). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151858 | Caiman Seal and Cut Technology Aesculap, Inc., Jul 21, 2015 |