Device product

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

Z-0205-2020

August 15, 2019

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc.
Event: Event 83655
Status: Terminated
Classification: Class II
Quantity: 166 total US: 15; OUS:151
Official record key: device-enforcement:Z-0205-2020

Official wording

Reason: 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

Code information: (SW) version V1.19.0 and V1.19.2 UDI: 00630414002026

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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