Recall Z-1374-2008 ยท IZI System, X-Ray, Angiographic
Philips Medical Systems North America Co. Phillips
Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
| Date | Sep 16, 2008 (initiated Mar 22, 2008) |
| Status | Terminated |
| Reason | Unexpected movement of the X-ray table may occur. These movements may lead to patient injury, e.g., an uncontrolled tilt may cause the patient to slip off. |
| Root cause | Software design |
| Action | On 3/22/08, the firm mailed letters to their customers via certified mail. The letter informed the customers of the recall, advising the customers to, "Use the emergency stop button or release the initiated movement command to halt undesired table movement. If you perform digital and conventional acquisition, you can avoid the problem by closing the single examinations daily or by clearing the patient database regularly." The letter further informed the customers that a Philips representative will be installing updated software at a future date. Contact Sarah Baxter at 425-487-7665 or Phil |
| Quantity | 22 units |
| Distribution | Nationwide Distribution -- including states of CA, CO, KY, TN, LA, MI, FL, MS, TX, VA, WI, MO, AZ, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032046 | PHILLIPS OMNIDIAGNOST ELEVA Philips Medical Systems, Inc., Jul 17, 2003 |