Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software ve

FDA device recall Z-2054-2015 · posted 2015-07-09 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

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.

Action taken

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 does not resume after Step 1, wait until the instrument displays System Ready, then restart the system software per the Vista Operator Guide, Section 2, Controlled Shutdown-Restart procedure. Issue 2: To prevent the Reagent Servers from temporarily losing synchronization, Siemens recommends setting the Auto Dispose option to No for methods assigned to Reagent Server 2 (see instructions below). These empty or expired reagent cartridges will now remain on the instrument and require the operator to unload them. Please consult your Vista Operators Guide or method Instructions for Use when results with flags and/or errors occur. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center-Technical Solutions at (800) 441-9250 or your local Siemens technical support representative.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

JJE

Quantity affected

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, Nethe

Date initiated

2015-05-21

Date posted

2015-07-09

Date terminated

2017-03-10

Location

Newark, DE

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