Recall Z-0543-2009 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions, USA, Inc
Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI; 10090235. Indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.
| Date | Jan 2, 2009 (initiated Jul 23, 2008) |
| Status | Terminated |
| Reason | If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report. |
| Root cause | Software design |
| Action | Consignees were notified of the problem via a Customer Safety Advisory Notice dated 7/23/08, which provided guidance on how to minimize the risk of the problem occurring, and told customers that a service patch will be installed when it becomes available. |
| Quantity | 306 of all products. |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040896 | MODIFICATION TO ENCOMPASS Heartlab, Inc., Jul 16, 2004 |