Recall Z-1312-2014— Philips Medical Systems (Cleveland), Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland), Inc., initiated 2014-02-11, terminated 2014-11-21. It names one FDA 510(k) clearance: K041577. Product: Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.. Reason: Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013..
- Recalling firm
- Philips Medical Systems (Cleveland), Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-11
- Terminated
- 2014-11-21
- Firm location
- Fitchburg, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
Reason for recall
Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013.
Data sourced from openFDA. This site is unofficial and independent of the FDA.