Atellica IM 1300/1600 Analyzers (2019-03-12)

Starting date:

March 12, 2019

Posting date:

March 28, 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-69432

• 
  Reason
• 
  Affected products

Affected Products

• A. Atellica IM 1300 Analyzer
• B. Atellica IM 1600 Analyzer

Reason

Siemens Healthcare Diagnostics is informing customers of the following two (2) issues that have been identified with Atellica Solution products, which are installed with Atellica Solution software (SW) versions v1.17SP2 (SMN 11469659) or lower:

1. For specific configurations of the Atellica Solution, the back cover on the Atellica Magline Transport for the Atellica CH 930 Analyzer, IM 1300 Analyzer, and IM 1600 Analyzer may not be detected as being open when the cover is open or removed.
2. Scanning new versions of IM test definitions (TDEF) resets the customer defined settings to default values in the TDEF.

Affected products