Recall Z-0979-2015 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
| Date | Jan 15, 2015 (initiated Dec 8, 2014) |
| Status | Terminated |
| Reason | Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion. |
| Root cause | Process control |
| Action | Philips sent an Urgent - Field Safety Notice letter dated December 4, 2014 to all affected customers. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, A Field Service Engineer will service the system to resolve the issue. For questions contact your local Philips representative or local Philips Healthcare office. |
| Quantity | 500 units |
| Distribution | US Nationwide Distribution - AR, AZ, CA, CO, FL, FL, GA, IL, IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, OR, PA, PA, SC, TN, TX, VA, and WA. The affected product was also distributed to one government consignee. The affected product was also distributed to the following foreign countries: Canada, A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012009 | MX8000 IDT CT SYSTEM Marconi Medical Systems, Inc., Sep 13, 2001 |
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |
| K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc., Jan 9, 2004 |
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |