Z-2251-2009

BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 Catalog number...

Name: Z-2251-2009 BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 Catalog number...
Creator: Brainlab AG
Published: 2009-08-12
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2009-08-12 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 Catalog number 20620 - Radiosurgery 3.5 and Catalog number 20630 -... on 2009-08-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2251-2009
Status: Terminated
Initiated: 2009-08-12
Posted: 2009-09-20
Terminated: 2011-03-16
Recalling firm: Brainlab, Inc.
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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: 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 tag: software
FDA 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 in commerce: 230 units
Distribution: Nationwide.
Product codes and lots: All versions of BrainSCAN or iPlan RT Dose software used with BrainLAB conical collimators.

Product code MUJ

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)