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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Medical

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 Class 2 Recall
Philips Medical
see related information
Date Posted October 28, 2008
Recall Status1 Open
Recall Number Z-0132-2009
Recall Event ID 49520
Premarket Notification
510(K) Numbers
K012009  K033326  K033357 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.
Code Information All units of Model numbers 455011203131 and 455011203191.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
For Additional Information Contact John R. Miller
440-483-7600
Manufacturer Reason
for Recall
Images not correlated: A leak between the Tube Interface and the Outlet Tube of the transducer may result in a failure to produce respiratory correlated images.
FDA Determined
Cause 2
DESIGN: Process Design
Action On 9/8/2008 Philips Medical Systems sent recall notification letters to their customers requesting they inventory their stock. They sent instructions to verify that the product is working properly. They are also sending Field Service Engineers to each customer to conduct field test.
Quantity in Commerce 507 units
Distribution Worldwide distribution: USA, Australia, Austria, Bahrain, Belgium, Canada, China, Czech Republic, Denmark, England, Finland, France, Germany, Israel, Italy, Japan, Jordan, Korea, Lithuania, Malaysia, Netherlands, Norway, New Zealand, Puerto Rico, South Africa, Saudi Arabia, Spain, Switzerland, Sweden, and Thailand.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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