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U.S. Department of Health and Human Services

Class 2 Device Recall BrainLAB Target Positioner for Leksell Headring

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  Class 2 Device Recall BrainLAB Target Positioner for Leksell Headring see related information
Date Initiated by Firm June 05, 2007
Date Posted July 03, 2007
Recall Status1 Terminated 3 on February 24, 2008
Recall Number Z-1010-2007
Recall Event ID 38170
510(K)Number K053584  
Product Classification Radiation therapy treatment Target Positioner - Product Code IWY
Product BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany; catalog/version number 40700-3A
Code Information Catalog/version number 40700-3A, all serial numbers
Recalling Firm/
Manufacturer		 Brainlab AG
Ammerthalstrasse 8
Kirchheim B. Muenchen Germany
For Additional Information Contact Ms. Kate Franco
800-597-5911
Manufacturer Reason
for Recall		 Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings and BrainLAB planning software resulted in a 1.25 mm shift in target area alignment during radiosurgery treatment.
FDA Determined
Cause 2		 Other
Action BrainLAB immediately notified all customers with the BrainSCAN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring, via e-mail on June 5, 2007. The Urgent Medical Device Product Notification letter dated June 4, 2007 included in the e-mail informed the customers that both the BrainSCAN and iPlan RT Dose treatment planning software calculates the isocenter position printed on the Target Positioner Overlays shifted 1.25 mm in cranial direction from the intended position, when the BrainLAB Target Positioner for Leksell Headring Revision A is used. The customers were instructed to cease using the BrainSCAN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring for treatment planning and patient set-up. An updated target positioner will be provided to the customers to correct the problem, estimated to be available in September 2007. Any questions were directed to their local BrainLAB Customer Support Representative or CAPA Manager Markus Hofman at 49-89-99-15-68-44 or 1-800-597-5911 in the U.S.
Quantity in Commerce 7 units
Distribution Ohio, Washington and France
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IWY and Original Applicant = BRAINLAB AG
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