Recall Z-2714-2011 ยท LNX
SCC Soft Computer
SoftReports versions 1.1.6.x and 1.1.7.x SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data
| Date | Jun 30, 2011 (initiated Jun 23, 2010) |
| Status | Terminated |
| Reason | SCC Soft Computer is issuing a correction for SoftReports Versions 1.1.6.x released 02/2008 and 1.1.7.x released 06/2008. Potential hazard - when using SoftReports Layout Designer, results displayed in the report may not match the patient information in the report header. |
| Root cause | Software design |
| Action | SCC Soft Computers sent a "RISK TO HEALTH NOTIFICATION TASK" letter dated June 9, 2010 to affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were offered an upgrade or hot fix. The letter requested acknowledgement of receipt of the task notification and permission to install the hot fix. |
| Quantity | 49 |
| Distribution | Worldwide Distribution--USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.