Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photome
FDA device recall Z-1703-2017 · posted 2017-03-19 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential for an elevation of greater than 15 percent in the ECREA result.
- Action taken
- Siemens mailed an Urgent Medical Device Correction Notice letter dated March 3, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens Technical Support Representative.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 2733 systems
- Distribution
- Worldwide Distribution - United States Nationwide and Puerto Rico, Canada, Qatar, Republic Korea, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, United Kingdom, Australia, Austria, Belgium, Cze
- Date initiated
- 2017-03-03
- Date posted
- 2017-03-19
- Date terminated
- 2018-07-03
- 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 |