PrecisePLAN 2.10 Treatment Planning System
FDA device recall Z-1406-2010 · posted 2010-04-16 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Error in dose rates which were calculated at exactly twice the expected values.
- Action taken
- As described in a prior related submission, Phase I - "Important Notice A285, Scrolling Selected Frame Dose Calculator Error" dated March 15, 2006 was distributed to affected customers to inform them of the potential and what steps should be taken. Phase 2 -- Software release PrecisePLAN 2.11 was released July 11, 2006 to correct this problem. All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. Phase 3 -- All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. The company is directing questions to the local Electa representative or to their offices in the U.K. at telephone 44 (0)-1293-654200.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 40 units
- Distribution
- Worldwide: IL, NY, PA, TN, Canada, China, Czech Republic, Germany, India, Israel, Italy, Mexico, Poland, Russia, Spain, Switzerland
- Date initiated
- 2006-03-15
- Date posted
- 2010-04-16
- Date terminated
- 2010-12-30
- 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 |