Enforcement Report - Week of July 11, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-1942-2012 |
| Classification | Class II |
| Code Info | Software R2.1 L 1 SP2 |
| Product Distributed Qty | 226 units |
| Reason For Recall | Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface |
Event Detail
| Event Id | 62270 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Philips Healthcare Inc. |
| City | Andover |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-14 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 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. |
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