Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.
This recall has been terminated (originally issued November 30, 2011).
- Company
- Elekta, Inc.
- Recall Initiated
- June 23, 2011
- Posted
- November 30, 2011
- Terminated
- January 31, 2012
- Recall Number
- Z-0307-2012
- Quantity
- 2
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.
Distribution
Nationwide Distribution (USA) - including the states of: NM and WA
Lot / Code Info
6107 and 6115
Root Cause
Labeling False and Misleading
Action Taken
Elekta sent an IMPORTANT NOTICE letter dated June 23, 2011 to affected customers. The notice identified the product, problem, and corrective actions to be taken by the user. The letter advise all customers to follow any instructions or recommendations covered in the Notice. The letter states that Elekta is working on a new software version and customers will receive the future version when released. For questions contact your local Elekta representative.