MLCi/MCLi2. Radiation therapy.
This recall has been terminated (originally issued May 23, 2012).
- Company
- Elekta, Inc.
- Recall Initiated
- April 19, 2012
- Posted
- May 23, 2012
- Terminated
- October 6, 2014
- Recall Number
- Z-1651-2012
- Quantity
- 386
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The Y2 diaphragm block was found loose.
Distribution
Nationwide Distribution including Puerto Rico.
Lot / Code Info
MRT 2424/MRT 14401
Root Cause
Nonconforming Material/Component
Action Taken
Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated April 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to carry out the recommended weekly physics check of the X-ray and light field size calibration. If an error is found, customers are instructed to contact their local Elekta service engineer.
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