Philips Pinnacle3 Software Recall Due to Incorrect Dose Calculation
Philips Medical Systems is recalling Pinnacle3 software version 10.0 because a defect in the dose engine may cause incorrect radiation therapy dose calculations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves incorrect radiation dose calculations, which poses a significant risk of injury to patients.
Plain-English summary
Philips Medical Systems, Inc. is recalling Pinnacle3 software version 10.0 (Model 459800200841). The recall involves four units distributed in Missouri, Florida, and Ohio. The software is used by qualified medical professionals to enter patient data, construct radiation therapy plans, and evaluate those plans.
The recall is due to a problem where the dose computed in planning mode is calculated incorrectly. Specifically, the dose engine is being passed the wrong snout position, which is used to determine the penumbra of the beam and calculate the source size. If this issue re-occurs, it could pose a risk to patients or users.
Affected units have the following system codes: 1439NML05A, 1117FMM025, DC090775040, and 1117FMM03J. Medical professionals using this software should contact Philips Medical Systems for further instructions on how to address the defect.
The recalled product
- Product
- Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualif
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- "System Code S/N" 1439NML05A
- 1117FMM025
- DC090775040
- 1117FMM03J.
Distribution
Related recalls
Same manufacturer · Philips Medical Systems, Inc.
See all →- ModeratePhilips Medical Systems Recalls Foot Switches for Bent Pedal Defect
FDA (Devices) · 2016-04-06
- ModeratePhilips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect
FDA (Devices) · 2016-04-06
- SeverePhilips IntelliVue Information Center iX Software Recall for Alarm Failure
FDA (Devices) · 2015-12-16
- HighPhilips INTEGRIS Cardio System Ceiling Suspension Recall
FDA (Devices) · 2015-12-09
- HighPhilips Allura BiPlane Ceiling Suspension System Recall for Fall Risk
FDA (Devices) · 2015-12-09
Same hazard · incorrect dose calculation
See all →- HighRayStation Radiation Therapy Software Recalled for Incorrect Dose Calculation
FDA (Devices) · 2023-07-05
- HighRayStation software recall due to incorrect total dose display
FDA (Devices) · 2021-05-26
- HighRayStation Treatment Planning Software Recalled for Dose Calculation Errors
FDA (Devices) · 2020-02-05
- HighElekta Monaco Radiation Treatment Planning System Software Recall
FDA (Devices) · 2019-12-18
- HighElekta Monaco RTP System Recalled for Potential Dose Calculation Errors
FDA (Devices) · 2019-10-02