Device product
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Z-0148-2020
Product summary
- Event
- Event 83529
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1125 units
- Official record key
device-enforcement:Z-0148-2020
Official wording
Reason: Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
Code information: Software version: V1.19.2 and below
Distribution pattern: Worldwide Distribution - US Nationwide Foreign: Argentina Australia Austria Bangladesh Belgium Brazil Bulgaria Canada Chile Colombia Czech Republic Denmark Ecuador Egypt Finland France Germany Greece Hungary India Indonesia Iran Ireland Israel Italy Japan Kuwait Latvia Malaysia Mexico Netherlands Nigeria Norway P.R. China Pakistan Philippines Poland Portugal Qatar Republic Korea Romania Russian Fed. Saudi Arabia Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay Vietnam
Derived failure modes
-
Unknown
Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below