Recall Z-2054-2015 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
| Date | Jul 9, 2015 (initiated May 21, 2015) |
| Status | Terminated |
| Reason | Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without notification. Issue #2: Timing issue in Vista 1500 may cause wrong reagent or no reagent delivery. This may lead to unflagged, unexpected low results and results flagged with assay errors. |
| Root cause | Software design (manufacturing process) |
| Action | Siemens sent an Urgent Medical Device Correction letter dated May 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer: For the corresponding issues listed above, please perform the following: Issue 1: If you experience this situation, sample processing can be resumed using the step(s) below: Step 1: From the Operation Icon select PAUSE, then immediately return to the Operation Icon and select Cancel PAUSE. Sample aliquotting should immediately resume. Step 2: If sample processing |
| Quantity | 2315 |
| Distribution | Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Austria, Australia, Belgium, Canada, Denmark, France, Finland, Germany, Japan, Italy, New Zealand, Netherlands, Czech Republic, Portugal, Republic Korea, Norway, Spain, Switzerland, Slovakia, Saudi Arabi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc., Jul 11, 2005 |