Recall Z-0302-2019 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-spe
| Date | Sep 4, 2018 |
| Status | Terminated |
| Reason | Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors that may result in partial set of images, inability to generate CT or PET images, incorrect scan parameters, or scanning the incorrect portion of the body. |
| Root cause | Software design |
| Action | Philips notified customers of these issues through Customer Information Letter (CIL) 88200518 to U.S. customers on 9/04/18 receive via USPS Certified mail. notifying them about the issues and temporary solutions available. Non-U.S. customers Non-U.S. customers will receive the letter through Philips Global Markets following local regulations. Field correction will consist of proactive field change order (FCO) release to be deployed to the impacted systems to correct all these issues.customers. if you need any further information or support concerning this issue, contact your local Philip |
| Quantity | 61 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123599 | INGENUITY DIGITAL PET/CT Philips Healthcare (Cleveland), Jul 12, 2013 |