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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 07, 2011
Recall Status1 Open
Recall Number Z-0032-2012
Recall Event ID 59853
Premarket Notification
510(K) Number
K072960 
Product Classification System, Image Processing, Radiological - 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, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Clinical measurements on true size printouts may be inaccurate
FDA Determined
Cause 2
DESIGN: 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 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 = LLZ and Original Applicant = CDP, LTD.
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