Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
This recall has been terminated (originally issued September 16, 2008).
- Recall Initiated
- March 22, 2008
- Posted
- September 16, 2008
- Terminated
- September 17, 2010
- Recall Number
- Z-1374-2008
- Quantity
- 22 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution -- including states of CA, CO, KY, TN, LA, MI, FL, MS, TX, VA, WI, MO, AZ, and NY.
Lot / Code Info
Product number 9896 002 04432. SN number: 43, 49, 52, 107, 123, 131, 152, 157, 171, 179, 185, 202, 266, 333, 337, 389, 408, 446, 485, 491, 514, 515; Site ID #: 506241, 500046, 521648, 522220, 520020, 533112, 533314, 533471, 533530, 535257, 535118, 535924, 540860, 541490, 539106, 547017, 547142, 549798, 547348, 550258, 553676, and 553235.
Root Cause
Software design
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.