Recall Z-0545-2019 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
| Date | Oct 18, 2018 |
| Status | Terminated |
| Reason | There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall |
| Root cause | Process control |
| Action | On October 18, 2018, Philips notices to their customers via courier service. Customers were advised to take the following actions: If any unusual noise is heard, discontinue use of the system immediately and contact your Philips representative for support. Field Order Change (FCO) 72800703 will be deployed to initiate an inspection of the front gantry cover. If the inspection finds evidence of weakening at this connection point, a temporary repair solution will be put in place to secure the cover for continued system use. FCO 72800704 will then be deployed to replace the affected front cove |
| Quantity | 6,343 units in total |
| Distribution | US Nationwide Distribution |
| 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 |