EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrated System is an in vit
FDA device recall Z-1991-2009 · posted 2009-09-29 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- incorrect results may be transmitted to LIS
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 359 units
- Distribution
- Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, Portugal, Slovenia, Spain and Switzerland.
- Date initiated
- 2009-07-14
- Date posted
- 2009-09-29
- Date terminated
- 2010-01-05
- Location
- Newark, DE
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA INTEGRATED SYSTEM (K051087) | Dade Behring, Inc. | 2005-07-11 |