Recall Z-1044-2015 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems, Inc.
Philips Multi Diagnost Eleva II
| Date | Feb 26, 2015 (initiated Oct 14, 2013) |
| Status | Terminated |
| Reason | The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips Healthcare Planned Action: 1. Software updates to SW R6.1.3 through Field Change Orders (FCOs) FCO70800140 and FCO70800142. 2. A customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. P |
| Quantity | 238 |
| Distribution | Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023441 | PHILIPS MULTIDIAGNOST ELEVA Philips Medical Systems, Oct 30, 2002 |