# FDA recall Z-0781-2019 > **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-09-26. ## Product Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Siemens Material Number (SMN) :11066000 ## Reason for recall Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample Handler Prime ## Distribution Worldwide distributions - US Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Poland, Portugal, Republic Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, U.A.E., United Kingdom, Vietnam. ## Key facts - **Recall number:** Z-0781-2019 - **Recalling firm:** Siemens Healthcare Diagnostics, Inc. - **Classification:** Class II - **Product type:** device - **Status:** Terminated - **Initiation date:** 2018-09-26 - **Report date:** 2019-02-06 - **Termination date:** 2020-06-24 - **Voluntary/Mandated:** Voluntary: Firm initiated - **Location:** Tarrytown, NY, United States ## Primary source FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0781-2019 ## Citation > AI Analytics. FDA recall Z-0781-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0781-2019. Source: US FDA. Licensed CC0. --- *[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*