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.
This recall has been terminated (originally issued July 5, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- June 14, 2012
- Posted
- July 5, 2012
- Terminated
- March 14, 2017
- Recall Number
- Z-1942-2012
- Quantity
- 226 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface
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.
Lot / Code Info
Software R2.1 L 1 SP2
Root Cause
Software design
Action Taken
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.