DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery
FDA device recall Z-0978-2014 · posted 2014-02-25 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
- Action taken
- Elekta sent an Important Field Safety Notice letter dated May 2013 to affected customers. The letter identified the scope, problem, clinical impact, solution, and safety reference. For question call +44 (0)1293 544422
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- IXI
- Quantity affected
- 35 units
- Distribution
- US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
- Date initiated
- 2013-05-01
- Date posted
- 2014-02-25
- Date terminated
- 2015-01-29
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DMLC IV-ERGO (K001163) | 3D Line USA, Inc. | 2000-10-23 |