Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1703-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.

Product Classification:

Class II

Date Initiated: March 3, 2017

Date Posted: April 5, 2017

Recall Number: Z-1703-2017

Event ID: 76690

Reason for Recall:

Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential for an elevation of greater than 15 percent in the ECREA result.

Status: Terminated

Product Quantity: 2733 systems

Code Information:

Device Listing D011374 Serial Number: All serial numbers

Distribution Pattern:

Worldwide Distribution - United States Nationwide and Puerto Rico, Canada, Qatar, Republic Korea, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, United Kingdom, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, and Portugal.

Voluntary or Mandated:

Voluntary: Firm initiated