Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.
This recall has been terminated (originally issued February 7, 2007).
- Company
- Elekta, Inc.
- Recall Initiated
- November 23, 2006
- Posted
- February 7, 2007
- Terminated
- May 14, 2008
- Recall Number
- Z-0421-2007
- Quantity
- 37 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Unexpected Diaphragm movement when manual field size modifications are not saved.
Distribution
Worldwide distribution ---- including USA states of AZ, AL, CA, CO, FL, GA, IA, MI, NV, OH, OK, PA, WA, WV and Country of Canada .
Lot / Code Info
Model number MRT 9871/ MRT 10601 (This issue affects Desktop Pro 6.0 and 6.1 users with a 3rd party R & V System, with the exception of Sigma Micro Users)
Root Cause
Software design
Action Taken
Consignees were notified by letter on/about 11/23/2006
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