Recall Z-1753-2017 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircula
| Date | Apr 6, 2017 (initiated Feb 24, 2017) |
| Status | Terminated |
| Reason | The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive. |
| Root cause | Nonconforming Material/Component |
| Action | Philips Healthcare sent an Urgent Field Safety Notice letter informing consignees of the issue through: Field Safety Notice (FSN) CLE17-006_88200502_88200503. Customers will be notified by direct communication from Philips Field Service Engineers (FSE). A copy of the FSN will be provided to customers by the FSE during the onsite visit for the inspection. A Business Reply form is attached to the FSN for customers to acknowledge receipt and understanding of the FSN. Customers with questions were instructed to contact the Customer Care Solutions Center at 1-800-722-9377. For questions regardin |
| Quantity | 27 systems |
| Distribution | Worldwide distribution - US including AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, VA, WA, WI, and WV. Internationally to Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, France, Germany, India, Israel, Italy, Japan, M |
| FDA record | Open on fda.gov |