FDA Enforcement Class II Terminated

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.

Recall: Z-1942-2012 · Reported July 11, 2012

Enforcement

Recall Number
Z-1942-2012
Event ID
62270
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Philips Healthcare Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
July 11, 2012
Initiation Date
June 14, 2012
Classification Date
July 5, 2012
Termination Date
March 14, 2017
Address
3000 Minuteman Road, N/A, Andover, MA, 01810, United States

Description

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.

Reason

Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface

Code Info

Software R2.1 L 1 SP2

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.

Quantity

226 units