Recall Z-0203-2015 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems, Inc.
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.
| Date | Dec 12, 2014 (initiated Oct 23, 2013) |
| Status | Terminated |
| Reason | It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips sent an Important Electronic Product Radiation Warning letter dated November 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by the customer: Please be aware that if this condition occurs, users will not be able to detect the situation prior to the interruption of the CT acquisition. However, if the INFORMATION message appears during a clinical study indicating to the operator that the scan did not complete successfully, Philips advises users to understand the following available |
| Quantity | 344 units worldwide, with approximately 114 units in the United States. |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, DC, DE, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, TX, VT, WA and WI., and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denma |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080927 | BRIGHTVIEW VCT IMAGING SYSTEM Philips Medical Systems (Cleveland), Inc., Apr 11, 2008 |