Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical
FDA device recall Z-1643-2015 · posted 2015-05-21 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users. Specifically, the dose engine is being passed the wrong snout position. The snout position is used to determine the penumbra of the beam which includes the calculation of the source si
- Action taken
- Philips Healthcare sent a "Field Safety Notification PROST-T-300-01-06" letter dated 20 April 2015 to their customers. The letter described the 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
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 4
- Distribution
- US Nationwide Distribution in the states of MO, FL, OH
- Date initiated
- 2015-04-23
- Date posted
- 2015-05-21
- Date terminated
- 2016-10-05
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (K041577) | Adac Laboratories | 2004-06-25 |