PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments.
FDA device recall Z-1476-2011 · posted 2011-03-02 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction.
- Action taken
- Elekta sent an Important Notice A308 letter dated January 28, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Elekta representative directly if they had any questions. .
- Root cause
- Other
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 277 units
- Distribution
- Worldwide Distribution - USA and the countries of Bulgaria, Switzerland, Czech Republic, Germany, Spain, France, Hungary, Ireland, Italy, Liechtenstein, Netherlands, Poland, Portugal, Sweden, Slovak R
- Date initiated
- 2008-01-28
- Date posted
- 2011-03-02
- Date terminated
- 2011-04-21
- 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 |
|---|---|---|
| PRECISEPLAN 2.0 (K022411) | Precision Therapy Intl., Inc. | 2002-09-20 |