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Class 2 Device Recall Philips Xcelera Connect |
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Date Initiated by Firm |
June 14, 2012 |
Date Posted |
July 05, 2012 |
Recall Status1 |
Terminated 3 on March 14, 2017 |
Recall Number |
Z-1942-2012 |
Recall Event ID |
62270 |
Product Classification |
Medical device data system - Product Code OUG
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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 MA 01810
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For Additional Information Contact |
978-687-1501
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Manufacturer Reason for Recall |
Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface
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FDA Determined Cause 2 |
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
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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.
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