Recall Z-2114-2013 ยท GKL Counter, Cell, Automated (Particle Counter)
Siemens Healthcare Diagnostics
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.
| Date | Aug 28, 2013 (initiated Jun 26, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root 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 proa |
| Quantity | 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, Kuwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971998 | ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM Bayer Corp., Aug 29, 1997 |