Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system
This recall has been terminated (originally issued March 28, 2011).
- Recall Initiated
- November 6, 2009
- Posted
- March 28, 2011
- Terminated
- April 6, 2011
- Recall Number
- Z-1834-2011
- Quantity
- 60 units
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
Reason for Recall
A problem in the software has the potential to be associated with the dose; when a template is created the user has the possibility to predefine organs. For the Target the user defines the max. dose and the min dose, for the OAR (Organs at Risk) the user only defines the max. dose. The firms engineering team determined that the software defect was repeatable.
Distribution
Worldwide distribution: USA including: CA, KY, MI, NJ and TN; and countries of: Canada and Mexico.
Lot / Code Info
Version 2.2, Part No. 081239953 Version 2.2.23 SPI Patch, Part No. 08164365
Root Cause
Software design
Action Taken
Affected consignees will be notified by the Customer Service Engineer to schedule a software update beginning November 2009.