Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany 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
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany
Lot Codes / Batch Numbers
All versions of BrainSCAN or iPlan RT Dose software used with BrainLAB conical collimators.
Products Sold
All versions of BrainSCAN or iPlan RT Dose software used with BrainLAB conical collimators.
Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany is recalling BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 Catalog due to Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical colli. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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. ***
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026