Philips GEMINI Imaging Systems Cl II

Company: Philips Medical Systems, Inc.
Date of Enforcement Report:2/122014
Class lI:

PRODUCT

Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
Recall Number Z-0932-2014

REASON
The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 12/4/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
386 units

DISTRIBUTION
Nationwide and Internationally

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About the author

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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