Pinnacle3 Radiation Therapy Planning System, Version 6.6c CD, Part Number 9104-0121C Rev. A
FDA device recall Z-0914-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- ADAC Laboratories
- Reason for recall
- A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe.
- Action taken
- A notification dated March 3, 2004 was sent to the customers. The notification gave recommendations for avoiding the problem and stated that updated software would be provided when it becomes available. Firm representatives made follow-up telephone calls to the consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 55
- Distribution
- The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.
- Date initiated
- 2004-03-03
- Date posted
- 2004-07-20
- Date terminated
- 2005-02-01
- Location
- Madison, WI
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