Atellica IM 1600 Analyzer (2018-12-12)

Starting date:

December 12, 2018

Posting date:

January 9, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68656

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  Reason
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  Affected products

Affected products

Atellica IM 1600 Analyzer

Reason

Siemens healthcare diagnostics is informing customers that the Atellica Solution Software (SW) version 1.16 (SMN 11316682) may generate motion errors during reagent scanning at the IM analyzer, after a system reboot, following a mechanics off state, or when exiting the diagnostics state after the reagent compartment shutter has been opened.

Affected products