Company:Philips Healthcare Inc
Date of Enforcement Report 7/11/12
Class ll:
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. Z-1942-2012
REASON
Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface .
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA on 2012-06-14. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
225 units
DISTRIBUTION
Nationwide and Internationally
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