Class 2 Device Recall ADVIA 120

• Date Initiated by Firm: June 26, 2013
• Date Posted: August 28, 2013
• Recall Status: Terminated on February 28, 2017
• Recall Number: Z-2114-2013
• Recall Event ID: 65852
• 510(K)Number: K971998
• Product Classification: Counter, cell, automated (particle counter) - Product Code GKL
• Product: ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
• Code Information: All serial numbers
• FEI Number: 2432235
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics; 511 Benedict Ave; Tarrytown NY 10591-5005
• Manufacturer Reason for Recall: The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during maintenance procedures.
• FDA Determined Cause: Equipment maintenance
• Action: Siemens sent an Urgent Device Correction Letter dated June 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed of the ADVIA 120 system displays a problem when raising and supporting the optics cover, immediately contact your service provider to arrange to have the cover struts serviced. If the optics cover will not stay in the up position, as required, do not perform maintenance procedures on the optics area until the hood struts have been replaced. Siemens field support will be proactively replacing the optics cover hood struts on a regular preventive maintenance cycle based on the age of the system. Please forward this notification to whomever you may have distributed this product We apologize for the inconvenience that this situation has caused. Thank you for your patience and continued support. This response form is to confirm receipt of the enclosed Siemens Healthcare Diagnostics Urgent Device Correction dated June 2013 regarding Optics Cover Struts (SMN 10309266). Please read each question and indicate the appropriate answer. Fax this completed form to Siemens Healthcare diagnostics at the fax number indicated at the bottom of this page. PLEASE FAX THIS COMPLETED FORM TO THE TECHNICAL SOLUTIONS CENTER AT (302) 631-7597.
• Quantity in Commerce: Domestic: 950 units; Foreign: 3369 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Austria, Australia, Belgium, Bosnia - Herzegovina, China, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Ireland, Iraq, Israel, Italy, Japan, Kenya, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Martinique, Malaysia, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Romania, Russian Republic, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom and Vietnam.
• 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 = GKL