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Recall Observatory FDA recall evidence

Device product

Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems. 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 multisensory technology for clinical use.

Z-1733-2014

April 14, 2014

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 68076
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-1733-2014

Official wording

Reason: A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard.

Code information: Product Siemens Material Number (SMN) Dimension Vista 500 Domestic: 10284473 International: 10488224 Dimension Vista 1500 Domestic: 10444801 International: 10444802 Serial #s: 0913900306  0913900355

Distribution pattern: Worldwide Distribution: US Distribution to states of: IL, OH and TN; and country of: Italy.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard.