The Recall Desk
HighFDA (Devices)·Z-2114-2013·Announced 2013-09-04

Siemens ADVIA 120 Hematology Analyzer Recall for Optics Cover Failure

Siemens is recalling ADVIA 120 Hematology Analyzers because gas struts may fail, causing the top optics cover to fall during maintenance.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (falling heavy cover) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Siemens Healthcare Diagnostics is recalling the ADVIA 120 Hematology Analyzer, catalog numbers SMN 10360958 and 10360959. The recall involves 950 units distributed in the United States and 3,369 units distributed in various foreign countries, including Austria, Australia, and the United Kingdom.

The recall is due to a defect in the gas struts that support the optics cover on top of the analyzer. Over time, these struts may lose effectiveness and fail to hold the cover in the open position. This failure could cause the cover to fall during maintenance procedures.

Users of the affected devices should contact Siemens Healthcare Diagnostics for instructions on how to address the issue. The recall covers all serial numbers for the specified catalog numbers.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers

Distribution

Distributed nationwide across the United States.