06

Mar

2013

Cl ll Philips EMINI TF Big BorePET & CT Systems

0

Company:Philips Medical Systems Inc.
Date of Enforcement Report 3/6/2013
Class ll:

PRODUCT

Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Recall Number Z-0883-2013

REASON
Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are ‘flipped’ and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems Inc., Cleveland, OH on 10/24/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
37

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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