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U.S. Department of Health and Human Services

Class 2 Device Recall BrainSCAN and iPlan RT Dose

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 Class 2 Recall
BrainSCAN and iPlan RT Dose
see related information
Date Posted September 20, 2009
Recall Status1 Open
Recall Number Z-2251-2009
Recall Event ID 52988
Premarket Notification
510(K) Numbers
K080888  K920879  K994413 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
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.
Code Information All versions of BrainSCAN or iPlan RT Dose software used with BrainLAB conical collimators.
Recalling Firm/
Manufacturer
Brainlab AG
Ammerthalstrasse 8
Kirchheim B. Muenchen
For Additional Information Contact Ms. Kate Franco
800-597-5911
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = BRAINLAB
510(K)s with Product Code = MUJ and Original Applicant = BRAINLAB AG
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