CLASS II Device recall · Reported 10 Feb 2016 · FDA Enforcement Report
DS/US Proton Feature with Pinnacle3 recalled by Philips Medical Systems
Philips Medical Systems is recalling DS/US Proton Feature with Pinnacle3, distributed nationwide in the US. The recall was initiated on 8 Jan 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0745-2016
- FDA event ID
- 73023
- Recalling firm
- Philips Medical Systems, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jan 2016
- FDA classified
- 2 Feb 2016
- Reported
- 10 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 8 Jan 2016 | Recall initiated by company | |
| 2 Feb 2016 | Classified by FDA | +25 days |
| 10 Feb 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
Where it was distributed
US: Nationwide Distribution in the states of FL, OH, and MO.
Questions about this recall
Is DS/US Proton Feature with Pinnacle3 recalled?
Yes. Philips Medical Systems recalled DS/US Proton Feature with Pinnacle3 on 8 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-0745-2016.
Why was it recalled?
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.
Which lots are affected?
Software Version 10.0.0 and 14.0.0
Where was it sold?
US: Nationwide Distribution in the states of FL, OH, and MO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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