Z-0915-04

Philips ADAC Pinnacle3 Version 6.4a Radiation Therapy Planning Software Package (Kit), Model Number...

Name: Z-0915-04 Philips ADAC Pinnacle3 Version 6.4a Radiation Therapy Planning Software Package (Kit), Model Number...
Creator: ADAC Laboratories
Published: 2004-03-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-03-03 / Terminated

FDA source

ADAC Laboratories began a recall of Philips ADAC Pinnacle3 Version 6.4a Radiation Therapy Planning Software Package (Kit), Model Number 9200-0613B-ENG on 2004-03-03. The reason FDA records is "Dose delivery in the wrong location may occur when using a Elekta Leksell headframe". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0915-04
Status: Terminated
Initiated: 2004-03-03
Posted: 2004-07-20
Terminated: 2005-02-01
Recalling firm: Philips North America LLC
Product: Philips ADAC Pinnacle3 Version 6.4a Radiation Therapy Planning Software Package (Kit), Model Number 9200-0613B-ENG
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Dose delivery in the wrong location may occur when using a Elekta Leksell headframe.
FDA 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 in commerce: 20 units
Distribution: The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.
Product codes and lots: Version 6.4a, Rev. A

Product code MUJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)