Recall Z-0089-2014 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. 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. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray
| Date | Oct 28, 2013 (initiated Sep 3, 2013) |
| Status | Terminated |
| Reason | Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position. |
| Root cause | Device Design |
| Action | Philips Healthcare sent an Urgent - Medical Device Correction letter (Field Safety Notice (FSN 88200462), dated August 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the notice with all members of their staff who need to be aware of the contents of the letter. Customers were asked to retain a copy with the equipment instruction for use. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Or |
| Quantity | 371 units |
| Distribution | Worldwide Distribution - USA including AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, NJ, ND, NE, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, and WI. Internationally to Canada, Algeria, Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Finland, Fra |
| 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 |