Recall Z-2204-2015 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Head Holder shipped with Ingenuity Core 128 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.
| Date | Jul 22, 2015 (initiated Mar 17, 2015) |
| Status | Terminated |
| Reason | A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system. |
| Root cause | Mixed-up of materials/components |
| Action | On 6/4/2015, the firm mailed Customer Information Letters. |
| Quantity | 55 units |
| Distribution | Worldwide Distribution-Product was shipped to the following states: AR, AR, AZ, CA, CO, CT, FL, GA, IA, IN, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV & WY, and to the following countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |