Siemens Dimension Vista (2016-03-30)

Starting date:

March 30, 2016

Posting date:

April 22, 2016

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-58036

• Reason
• Affected products

Affected products 

A. DIMENSION VISTA SYSTEM-DIMENSION VISTA 1500 ANALYZER

B. DIMENSION VISTA SYSTEM-DIMENSION VISTA 1500 ANALYZER

C. DIMENSION VISTA SYSTEM-DIMENSION VISTA 500 ANALYZER

Reason

Siemens Healthcare Diagnostics has received customer complaints of discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare Diagnostics has confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in sample racks that are front loaded on the Dimension Vista System. Omission of the aliquot probe rinse may result in carryover of residual sample estimated up to 10% when the sample is dispensed into the aliquot well. Carryover of residual sample from the outside of the aliquot probe into the sample tube is estimated at less than 0.1%.

Affected products