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U.S. Department of Health and Human Services

Class 2 Device Recall OmniDiagnost Eleva

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  Class 2 Device Recall OmniDiagnost Eleva see related information
Date Initiated by Firm October 07, 2010
Date Posted March 16, 2011
Recall Status1 Terminated 3 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 2
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 and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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