Class 2 Device Recall OmniDiagnost Eleva

• Date Initiated by Firm: October 07, 2010
• Date Posted: March 16, 2011
• Recall Status: Terminated on February 23, 2012
• Recall Number: Z-1657-2011
• Recall Event ID: 57777
• 510(K)Number: K032046
• Product Classification: x-ray system - Product Code IZI
• Product: Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO70800115.
• Code Information: Site Numbers: 520020, 522220, 533112, 533314, 533471, 535257, 539106, 541490, 547017, 547348, 549798, 553676, 42036161, 42383151, 43180366, and 43680651.
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Co. Phillips; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Philips Healthcare Call Center; 800-722-9377 Ext. 5
• Manufacturer Reason for Recall: A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees. The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available). The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system. Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.
• Quantity in Commerce: 16 units distributed in US
• Distribution: Devices were distributed through out the US.
• 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