Recall Z-0914-04 ยท MUJ System, Planning, Radiation Therapy Treatment
ADAC Laboratories
Pinnacle3 Radiation Therapy Planning System, Version 6.6c CD, Part Number 9104-0121C Rev. A
| Date | Jul 20, 2004 (initiated Mar 3, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 55 |
| Distribution | The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.