Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiogra
FDA device recall Z-1374-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- 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.
- Action taken
- 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 Philips Call Center at 800-722-9377, #5, #2 if you have questions.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 22 units
- Distribution
- Nationwide Distribution -- including states of CA, CO, KY, TN, LA, MI, FL, MS, TX, VA, WI, MO, AZ, and NY.
- Date initiated
- 2008-03-22
- Date posted
- 2008-09-16
- Date terminated
- 2010-09-17
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILLIPS OMNIDIAGNOST ELEVA (K032046) | Philips Medical Systems, Inc. | 2003-07-17 |