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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Medical

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 Class 2 Device Recall Philips Medicalsee related information
Date Initiated by FirmSeptember 22, 2008
Date PostedOctober 28, 2008
Recall Status1 Terminated 3 on March 01, 2012
Recall NumberZ-0132-2009
Recall Event ID 49520
510(K)NumberK012009 K033326 K033357 
Product Classification pulmonary toolkit - Product Code KPS
ProductRespiratory 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 OH 44143-2131
For Additional Information ContactJohn 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		Process design
ActionOn 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 Commerce507 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = KPS
510(K)s with Product Code = KPS
510(K)s with Product Code = KPS
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