Philips Pinnacle3 Version 6.4a Radiation Therapy Planning Software CD, Part Number 9104-0121B, Rev. A
FDA Recall Z-0916-04 · Posted 2004-07-20
Recalling FirmADAC Laboratories
Recall StatusTerminated
Product CodeMUJ
Date Initiated2004-03-03
Date Terminated2005-02-01
Reason for Recall
Dose delivery in the wrong location may occur when using a Elekta Leksell headframe.
Firm 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.
Root Cause
Other
Distribution Pattern
The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.