BrainLab Micro-Multileaf-Collimator, model 41600; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany. The mMLC
FDA device recall Z-1544-2009 · posted 2009-07-02 · Terminated
Recall details
- Recalling firm
- Brainlab AG
- 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.
- 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).
- Root cause
- Other
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 13 units
- 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.
- Date initiated
- 2009-03-19
- Date posted
- 2009-07-02
- Date terminated
- 2010-08-19
- Location
- Kirchheim B. Muenchen, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRAINLAB MICRO MULTI-LEAF COLLIMATOR (K970586) | Brainlab Med. Computersysteme GmbH | 1997-05-12 |