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FDA device recall Z-1944-2014 · posted 2014-06-30 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.
- Action taken
- An urgent medical device correction notice, dated May 20, 2014, was sent to end users to provide instructions to avoid potential risks associated with the software defect, until changes can be made by a Siemens technical representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 336
- Distribution
- Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spai
- Date initiated
- 2014-05-20
- Date posted
- 2014-06-30
- Date terminated
- 2015-08-10
- Location
- Newark, DE
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