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 S
FDA device recall Z-2714-2011 · posted 2011-06-30 · Terminated
Recall details
- Recalling firm
- SCC Soft Computer
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LNX
- Quantity affected
- 49
- Distribution
- Worldwide Distribution--USA (nationwide) and the country of Canada.
- Date initiated
- 2010-06-23
- Date posted
- 2011-06-30
- Date terminated
- 2012-07-26
- Location
- Clearwater, FL
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