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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 Medical see related information
Date Initiated by Firm September 01, 2011
Date Posted October 07, 2011
Recall Status1 Terminated 3 on March 13, 2017
Recall Number Z-0032-2012
Recall Event ID 59853
510(K)Number K072960  
Product Classification Picture Archiving and Communication System - Product Code LLZ
Product MDC PACS - release R2.3 SP1 .
Phillips Healthcare
Andover, Massachusetts

A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Code Information Sofware release R2.3 SP1
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 Clinical measurements on true size printouts may be inaccurate
FDA Determined
Cause 2		 Software design
Action Philips Medical notified all affected customers with a "Field Safety Notice" dated August 2011. The letter provides instructions to the customer for how to avoid the problem. Customers are informed that until the software upgrade is recieved from Philip, do not use the true-size printing feature if the system is configured for more than one DICOM printer. Customers will be instructed that they will receive a software upgrade when it is available. For questions on this recall contact Philips representative at (800) 722-9377.
Quantity in Commerce 20 units
Distribution Worldwide Distribution: Nationwide distribution including Puerto Rico; and the countries of Argentina, Brazil, China, France, Greece, India, Israel Mexico, and Turkey.
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 = LLZ and Original Applicant = CDP, LTD.
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