Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and softwa
FDA device recall Z-0841-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Gyrus Medical, Inc
- Reason for recall
- The generator may malfunction when used in close proximity to a monopolar generator.
- Action taken
- On December 05, 2003, the firm sent recall notices to their affected customers by Certified Mail. The customers were notified that the firm would call them to arrange for pick up and correction of the device.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 14
- Distribution
- Nationwide throughout the United States.
- Date initiated
- 2003-12-05
- Date posted
- 2004-07-20
- Date terminated
- 2006-12-28
- Location
- Maple Grove, MN
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