GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
FDA device recall Z-1218-2017 · posted 2017-02-16 · Terminated
Recall details
- Recalling firm
- Aesculap Implant Systems LLC
- Reason for recall
- Generators may have a faulty component which could impact the proper functioning of the device.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 24 generators
- Distribution
- USA (nationwide Distribution).
- Date initiated
- 2017-01-09
- Date posted
- 2017-02-16
- Date terminated
- 2017-06-14
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Caiman Seal and Cut Technology (K151858) | Aesculap, Inc. | 2015-07-21 |