FDA Medical Device Recalls (openFDA)
ADAC Laboratories: Pinnacle3 Radiation Therapy Planning System, Version 6.6c Kit, Model Number 9200-0613C-ENG
- Recall number
- Z-0912-04
- Recalling firm
- ADAC Laboratories
- Product
- Pinnacle3 Radiation Therapy Planning System, Version 6.6c Kit, Model Number 9200-0613C-ENG
- Status
- Terminated
- Initiated
- 2004-03-03
- Posted
- 2004-07-20
- Terminated
- 2005-02-01
- 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.
- Lot, serial or model codes
- Version 6.6c
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 3004022368
- Firm city
- Madison
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28