Recall Z-1942-2012— Philips Healthcare Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-06-14, terminated 2017-03-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface.
- Recalling firm
- Philips Healthcare Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-14
- Terminated
- 2017-03-14
- Firm location
- Andover, MA, United States
Product 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 for recall
Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface
Data sourced from openFDA. This site is unofficial and independent of the FDA.