The Recall Desk
HighFDA (Devices)·Z-1312-2014·Announced 2014-04-09

Philips Pinnacle3 Radiation Therapy Planning System Software Recall

Philips is recalling Pinnacle3 Radiation Therapy Planning System software version 9.0 due to a defect that can cause incorrect beam geometry.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that can cause incorrect beam geometry in radiation therapy, which poses a risk of harm to patients. The source text does not report any specific injuries or illnesses, fitting the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems (Cleveland), Inc. is recalling the Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. The recall involves units manufactured between September 29, 2009, and December 1, 2013.

The recall was initiated because Philips determined that a software nonconformance can cause incorrect beam geometry. This defect affects the planning of radiation therapy treatments.

The affected software was distributed worldwide, including in the United States and various international locations. The source text does not specify the total number of affected units or provide specific instructions for consumers or healthcare providers on how to proceed.

The recalled product

Product
Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
Manufacturer
Philips Medical Systems (Cleveland), Inc.
Category
Medical Device — Radiation Therapy Planning Software
Hazard
Affected units
1,016

Distribution

Distributed in 49 states:

Related recalls

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