Recall Z-1547-2009
Brainlab AG · initiated March 19, 2009
Product
BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model 41600-06, -6 A; BrainLAB AG, Acetylesterase 12, 85622 Edicendi, Germany. The m MLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation.
Codes / lots: Model 41600-6A; Serial Number 41600-6A/24143.
Reason for recall
The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multileaf-Collimator (mMLC) during patient treatment.
FDA-determined cause: Other
Action taken
BrainLAB AG issued an "Urgent Field Safety Notice/Product Notification" letter dated March 19, 2009 informing all customers of the affected device. Consignees were instructed on proper steps to take to avoid further issues. In addition, the most current m3 mMLC user guide, version 7.4, was scheduled to be sent to users in April 2009. For further questions, contact BrainLAB AG by phone at 1-800-597-5911).
Details
- Recall number
- Z-1547-2009
- Initiated
- March 19, 2009
- Posted by FDA
- July 2, 2009
- Terminated
- August 19, 2010
- Product code
- IYE – Accelerator, Linear, Medical
- Quantity
- 1 unit
- Distribution
- Nationwide Distribution - AL, CA, CO, FL, GA, IL, KS, KY, LA, MD, MI, MN, MS, ME, NJ, NY, OR, TN, TX, UT, VA, WV, WA and WI.
- Recalling firm
- Brainlab AG, Kirchheim B. Muenchen
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1544-2009 | BrainLab Micro-Multileaf-Collimator, model 41600; BrainLab AG, Kapellenstrasse 12, 85622…The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended… | 03/19/2009Terminated |
| Z-1545-2009 | BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3…The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended… | 03/19/2009Terminated |
| Z-1546-2009 | BrainLab M3 Micro-Multileaf-Collimator for Siemens Mevatron Digital Type III with MLC…The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended… | 03/19/2009Terminated |