Siemens Healthcare Diagnostics, Inc. Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

Recommended Action

Per FDA guidance

Siemens issued an Urgent Medical Device Correction (UMDC) to US customers via FedEx on August 15, 2019. The UFSN was electronically issued to all OUS Siemens sites, with affected customers, for distribution, as well as regional reporting to their respective local competent authority on August 16, 2019. The UMDC/UFSN explain the behavior(s) to users and provide actions to be taken to correct the behavior. Customers are requested to return the Effectiveness Check Form, in the UMDC/UFSN via fax or email. Siemens Healthcare Diagnostics Inc. has released an updated software (SW) version (V) 1.20.0, which corrects the reported behavior(s). A Mandatory Update (MU) campaign has been launched to install the new SW V on all systems, whether or not they are impacted by these behaviors.