Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3
FDA device recall Z-0430-2014 · posted 2013-12-02 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1
- Action taken
- A notification letter was sent to consignees in May 2013.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 776
- Distribution
- Worldwide Distribution: USA (nationwide) and iinternationally to Canada.
- Date initiated
- 2013-05-20
- Date posted
- 2013-12-02
- Date terminated
- 2014-04-10
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA INTEGRATED SYSTEM (K051087) | Dade Behring, Inc. | 2005-07-11 |