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Terminated

Pinnacle3 Radiation Therapy Planning System, Version 7.0e Kit, Model Number 9200-9052A-ENG

FDA Recall Z-0911-04 · Posted 2004-07-20

Recalling FirmADAC Laboratories
Recall StatusTerminated
Product CodeMUJ
Date Initiated2004-03-03
Date Terminated2005-02-01
Product Quantity55

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.

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032724PINNACLE3 RADIATION THERAPY PLANNING SYSTEMAdac Laboratories · 2003-10-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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