Recall Z-1942-2012 ยท OUG Medical Device Data System
Philips Healthcare Inc.
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 o
| Date | Jul 5, 2012 (initiated Jun 14, 2012) |
| Status | Terminated |
| Reason | Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface |
| Root cause | Software design |
| Action | 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. |
| Quantity | 226 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.