Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931,
FDA device recall Z-2200-2015 · posted 2015-07-22 · Terminated
Recall details
- Recalling firm
- Philips Electronics North America Corporation
- Reason for recall
- Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl.
- Action taken
- Consignees were sent on 7/31/2014 a Philips "Urgent Field Safety Notice" dated 2014-July 20. The letter described the problem, product involved in the recall and the action that should be taken by the customers. For questions contact Customer Care Solutions Center at 1-800-722-9377. UPDATE: A second Philips letter dated 2 July 2015 was sent in August 6, 2015. This letter updated the recall to incorporate the additional products being recalled.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 1642
- Distribution
- Worldwide Distribution-US: All states in the US including DC and PR. OUS: Australia, Austria, Bangladesh, Belgium, Brazil, China, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy,
- Date initiated
- 2014-07-31
- Date posted
- 2015-07-22
- Date terminated
- 2019-05-08
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (K041577) | Adac Laboratories | 2004-06-25 |