DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
FDA device recall Z-2157-2013 · posted 2013-09-04 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
- Action taken
- Important Field Safety Notices 200 01 406 030 (Changes to your system to improve the safe operation of DMLC) and 200 01 602 031 (Changes to your system to improve the safe operation of 3DLINE DMLC) letters were sent to customers on 8/15/2013 advising them of the issue and recommendations to resolve either by upgrading their system or to discontinue a clinical use of the device.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IXI
- Quantity affected
- 31
- Distribution
- Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.
- Date initiated
- 2013-08-15
- Date posted
- 2013-09-04
- Date terminated
- 2015-07-28
- Location
- Atlanta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DMLC IV-ERGO (K001163) | 3D Line USA, Inc. | 2000-10-23 |