Monaco Product Usage: Planning of radiation therapy
FDA device recall Z-2007-2012 · posted 2012-07-12 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
- Action taken
- Elekta sent an Important Safety Notice to affected customers. The notice identified the affected product, problem, clinical impact and actions to be taken. The notice inform customers of how the issue will be resolved and instructions to follow when it is available.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 38
- Distribution
- US Nationwide Distribution - including the states of: CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI
- Date initiated
- 2012-06-21
- Date posted
- 2012-07-12
- Date terminated
- 2014-04-01
- Location
- Norcross, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONACO RTP SYSTEM (K110730) | Computerized Medical Systems, Inc. | 2011-06-24 |