Recall Z-1991-2009 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
| Date | Sep 29, 2009 (initiated Jul 14, 2009) |
| Status | Terminated |
| Reason | incorrect results may be transmitted to LIS |
| Root cause | Software design |
| Action | Siemens issued an "Urgent Device Correction" letter dated July 2009. The letter informed the user of the affected product including instructions for avoiding the problem. For further information, contact Siemens Healthcare Diagnostics Technical Solution Center at 1-800-441-9250. |
| Quantity | 359 units |
| Distribution | Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, Portugal, Slovenia, Spain and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc., Jul 11, 2005 |