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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Xcelera Connect

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 Class 2 Recall
Philips Xcelera Connect
see related information
Date Posted July 05, 2012
Recall Status1 Open
Recall Number Z-1942-2012
Recall Event ID 62270
Product Classification Medical Device Data System - Product Code OUG
Product Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.
Code Information Software R2.1 L 1 SP2
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Healthcare sent an "URGENT-FIELD SAFETY NOTICE" letter dated June 1, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Philips representative will contact customers when the upgrade becomes available. Contact your local Philips Representative for questions concerning this issue.
Quantity in Commerce 226 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Argentina, Chile, Denmark , Estonia, Finland, France, Germany ,Hong Kong, Ireland, Italy, Malaysia, Netherlands, Poland, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Taiwan, United Kingdom, and Utd. Arab. Emir.
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.
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