Recall Z-2083-2013
Brainlab AG · initiated July 16, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Part No. 43410
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: Device Design
Action taken
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
Details
- Recall number
- Z-2083-2013
- Initiated
- July 16, 2013
- Posted by FDA
- August 26, 2013
- Terminated
- March 13, 2017
- Product code
- IYE – Accelerator, Linear, Medical
- Quantity
- 6 units
- Distribution
- Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.
- Recalling firm
- Brainlab AG, Feldkirchen