High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator.
This recall has been terminated (originally issued August 2, 2008).
- Recall Initiated
- January 30, 2008
- Posted
- August 2, 2008
- Terminated
- August 18, 2010
- Recall Number
- Z-1459-2008
- Quantity
- 3 units subject to correction
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient.
Distribution
Nationwide Distribution including states of NC, FL and CA.
Lot / Code Info
Serial Number 1009.
Root Cause
Software design
Action Taken
Consignees were notified by a Medical Device Notification letter sent on 01/29/2008. The letter advised users to cease use of the device until a corrected version of the software is available. A representative will contact users to upgrade the application once the revised software has been validated and released for distribution.
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