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Terminated

Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.

FDA Recall Z-1374-2008 · Posted 2008-09-16

Recall StatusTerminated
Product CodeIZI
Date Initiated2008-03-22
Date Terminated2010-09-17
Product Quantity22 units

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution -- including states of CA, CO, KY, TN, LA, MI, FL, MS, TX, VA, WI, MO, AZ, and NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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