Siemens Healthcare Diagnostics: Medical Device Recall in 2013 - (Recall #: Z-2114-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 26, 2013

Date Posted: September 4, 2013

Recall Number: Z-2114-2013

Event ID: 65852

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.

Status: Terminated

Product Quantity: Domestic: 950 units; Foreign: 3369 units

Code Information:

All serial numbers

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated