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Terminated

GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories

FDA Recall Z-1218-2017 · Posted 2017-02-16

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeGEI
Date Initiated2017-01-09
Date Terminated2017-06-14
Product Quantity24 generators

Reason for Recall

Generators may have a faulty component which could impact the proper functioning of the device.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

USA (nationwide Distribution).

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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