DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #45980020
FDA device recall Z-0745-2016 · posted 2016-02-02 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.
- Action taken
- Philips sent an "Urgent Medical Device Correction" letter dated 16-DEC-2015 to affected customers. The letter described the Affected Products, Problem Description, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer / User, Actions Planned by Philips and Further Information and Support (contact Philips Customer Care Solutions Center at 1-800-722-9377 ).
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 3
- Distribution
- US: Nationwide Distribution in the states of FL, OH, and MO.
- Date initiated
- 2016-01-08
- Date posted
- 2016-02-02
- Date terminated
- 2016-10-05
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (K130992) | Philips Medical Systems (Cleveland), Inc. | 2013-06-14 |