Class 2 Device Recall syngo Lab Data Manager

• Date Initiated by Firm: May 20, 2014
• Date Posted: June 30, 2014
• Recall Status: Terminated on August 10, 2015
• Recall Number: Z-1944-2014
• Recall Event ID: 68394
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
• Code Information: syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 Gbc Dr Ms 514; PO BOX 6101; Newark DE 19702-2466
• For Additional Information Contact: Customer Support; 800-441-9250
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 336
• Distribution: Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.