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U.S. Department of Health and Human Services

Class 2 Device Recall 43410 FRAMELESS SRS QA TARGET POINTER

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  Class 2 Device Recall 43410 FRAMELESS SRS QA TARGET POINTER see related information
Date Initiated by Firm July 16, 2013
Date Posted August 26, 2013
Recall Status1 Terminated 3 on March 13, 2017
Recall Number Z-2083-2013
Recall Event ID 65773
510(K)Number K073018  
Product Classification Accelerator, linear, medical - Product Code IYE
Product BRAINLAB; FRAMELESS SRS QA TARGET POINTER

Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.

Code Information Part No. 43410
Recalling Firm/
Manufacturer		 Brainlab AG
Kapellenstrasse 12
Feldkirchen Germany
Manufacturer Reason
for Recall		 The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap.
FDA Determined
Cause 2		 Device Design
Action BrainLab sent an "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" dated July 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of the SRS QA Target Pointer. Consignees can instead use the Phantom Pointer feature until Brainlab can provide replacement hardware. Brainlab anticipates being able to provide all impacted facilities with replacement hardware by the end of July 2013. We sincerely apologize for any inconvenience and thank you in advance for your co-operation. If you require further clarification, please feel free to contact your local Brainlab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers) or by E-mail: support@brainlab.com. Fax Brainlab AG: + 49 89 99 15 68 33
Quantity in Commerce 6 units
Distribution Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.
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 = IYE and Original Applicant = BRAINLAB AG
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