Atellica IM 1300/1600 Analyzer (2021-05-20)

Starting date:

May 20, 2021

Posting date:

June 10, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-75779

Last updated:
2021-06-10

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  Reason
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  Affected products

Affected Products 

A. Atellica IM 1300 analyzer

B. Atellica IM 1600 analyzer

Reason

Siemens has identified a set of valves that are used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers that may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.

Affected products