Siemens Healthcare Diagnostics Dimension Vista Systems recall: Software Issue
Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro…
Why was Siemens Healthcare Diagnostics Dimension Vista Systems recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Siemens Material Number (SMN): 10284473, 10488224, 10444801, 10444802
- Product
- Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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 Arabia, Slovenia, and United Kingdom,
- Recall date
- July 15, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)