Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
This recall has been terminated (originally issued March 17, 2010).
- Company
- Elekta, Inc.
- Recall Initiated
- July 2, 2007
- Posted
- March 17, 2010
- Terminated
- March 25, 2010
- Recall Number
- Z-1158-2010
- Quantity
- 19
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Need to modify the closing speed of the shielding doors in the event of an emergency exit
Distribution
Worldwide Distribution -- USA, including states of AR, AZ, CA, FL, IL, MI, MN, MS, NJ, OH, OR, PA, UT, VA and countries of France and United Kingdom.
Lot / Code Info
Serial Numbers: 6002, 6003, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, and 6030.
Root Cause
Other
Action Taken
A field action (FCO TN-07-0007) has been performed to modify the shielding door speed on all sites in clinical use. A second Field Change Order 200 069 "Replacement of Door Servo Board" dated 9/16/08 was released.
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