FDA Medical Device Recalls (openFDA)
Brainlab AG: BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 Catalog number 20620 - Radiosurgery 3.5 and Catalog number 20630 - Circular ARC SRS/SRT Planning. The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions. It is intended to be used by experienced and trained health professionals.
- Recall number
- Z-2251-2009
- Recalling firm
- Brainlab AG
- Product
- BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 Catalog number 20620 - Radiosurgery 3.5 and Catalog number 20630 - Circular ARC SRS/SRT Planning. The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions. It is intended to be used by experienced and trained health professionals.
- Status
- Terminated
- Initiated
- 2009-08-12
- Posted
- 2009-09-20
- Terminated
- 2011-03-16
- Reason
- Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may lead to serious injury of the patient.
- Root cause
- Other
- Action
- BrainLAB AG issued an "Urgent Field Safety Notice" letter dated August 12, 2009 informing all customers of the BrainLab radiotherapy planning software using conical collimators of the important safety checks to avoid the failure to apply and verify an adequate jaw-shaped field size and field position at the LINAC for the used conical collimator(s) or the failure to mount and verify the correct, intended conical collimator. Consignees were instructed on proper steps to take to avoid further issues. For further questions, contact BrainLAB AG by phone at 1-800-597-5911. *** On February 1, 2010, BrainLab sent supplemental letters to 50 of the accounts who received the August 12, 2009 letter and have Novalis Dose Delivery Systems (excluding all Novalis Tx systems). The accounts were informed that in addition to the safety checks listed in the August letter, BrainLab will be installing a mandatory software modification on their systems that limits the field size to a maximum of 4x4 cm2 when the conical collimators are inserted. The accounts would be contacted by a service representative within the next six weeks to schedule the update. Any questions were directed to BrainLab at 1-800-597-5911. ***
- Quantity
- 230 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- All versions of BrainSCAN or iPlan RT Dose software used with BrainLAB conical collimators.
- 510(k) numbers
- K002509, K080888, K920879, K994413
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 3002619595
- Firm city
- Kirchheim B. Muenchen
- Firm state
- not on file
- Firm country
- Germany
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
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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