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U.S. Department of Health and Human Services

Class 3 Device Recall VersaCell X3 Solution and VersaCell X3 Expansion Pack

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  Class 3 Device Recall VersaCell X3 Solution and VersaCell X3 Expansion Pack see related information
Date Initiated by Firm April 25, 2014
Date Posted June 19, 2014
Recall Status1 Terminated 3 on April 16, 2015
Recall Number Z-1832-2014
Recall Event ID 68320
510(K)Number K970227  
Product Classification Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
Product VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.
Code Information Siemens Material Numbers: Instrument 10793839, Expansion Pack 10913528
Recalling Firm/
Manufacturer		 Siemens Medical Solutions Diagnostics
62 Flanders-Bartley Rd
Flanders NJ 07836-4715
For Additional Information Contact
877-229-3711
Manufacturer Reason
for Recall		 The keyboard and monitor may not be properly secured to the monitor arm.
FDA Determined
Cause 2		 Device Design
Action Siemen's Healthcare Diagnostics sent an Urgent Medical Device Correction letter dated April 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return teh Field Correction Effectiveness Check form attached to the letter within 30 days by fax to 302-631-7597. Inspect the monitor, keyboard and bracket assembly. If the screw and washer assembly is secure as shown in Figure 1, the monitor and keyboard assembly is safe to use. After making adjustments or repositioning the monitor, keyboard and bracket assembly, inspect the screw adn washer to ensure it is ssecure as shown in Figure 1. If there is a gap between the underside of the monitor support bracket and cylindrical mounting feature as shown in Figure 2, contact your Siemens technical support representative to schedule a service visit as soon as possible. Front load and manage samples directly on the connected instruments until your Siemens technical support representative addresses the issue. Customers were instructed to retain the letter with their laboratory records, and forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 877-229-3711.
Quantity in Commerce 19 units
Distribution Worldwide Distribution - USA including Iowa and New York and Internationally to Canada, Chile, France, India, Italy, Malaysia, Peru, Korea, and the United Kingdom.
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.
510(K) Database 510(K)s with Product Code = LXG and Original Applicant = DPC CIRRUS
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