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Terminated

Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000

FDA Recall Z-0205-2020 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2019-08-15
Date Terminated2022-05-05
Product Quantity166 total US: 15; OUS:151

Reason for Recall

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

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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