Class 2 Device Recall OmniDiagnost Eleva

• Date Initiated by Firm: March 22, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on September 17, 2010
• Recall Number: Z-1374-2008
• Recall Event ID: 47489
• 510(K)Number: K032046
• Product Classification: Angiographic X-ray System - Product Code IZI
• Product: Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Co. Phillips; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Sarah Baxter; 425-487-7665
• Manufacturer 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.
• FDA Determined 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 Philips Call Center at 800-722-9377, #5, #2 if you have questions.
• Quantity in Commerce: 22 units
• Distribution: Nationwide Distribution -- including states of CA, CO, KY, TN, LA, MI, FL, MS, TX, VA, WI, MO, AZ, and NY.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IZI