Monaco RTP System. Radiation treatment planning.
FDA device recall Z-0841-2013 · posted 2013-02-20 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
- Action taken
- Elekta provided customers with an "Important Safety Notice - Dose Display Not Matching Beam Geometry - Monaco RFC 35748". The notice identified the product, problem, and actions to be taken by the customers. Contact the form at 800-878-4267 for questions relating to this notice.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 13
- Distribution
- Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.
- Date initiated
- 2013-02-11
- Date posted
- 2013-02-20
- Date terminated
- 2014-01-21
- Location
- Atlanta, GA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONACO RTP SYSTEM (K110730) | Computerized Medical Systems, Inc. | 2011-06-24 |