ADAC Laboratories Philips Pinnacle3 Version 6.4a Radiation Therapy Planning Software CD, Part Number 9104-0121B, Rev. A Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Pinnacle3 Version 6.4a Radiation Therapy Planning Software CD, Part Number 9104-0121B, Rev. A
Brand
ADAC Laboratories
Lot Codes / Batch Numbers
Version 6.4a, Rev. A
Products Sold
Version 6.4a, Rev. A
ADAC Laboratories is recalling Philips Pinnacle3 Version 6.4a Radiation Therapy Planning Software CD, Part Number 9104-0121B, Rev. due to Dose delivery in the wrong location may occur when using a Elekta Leksell headframe.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Dose delivery in the wrong location may occur when using a Elekta Leksell headframe.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026