PlainRecalls
FDA Devices Moderate Class II Terminated

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 i

Reported: June 18, 2014 Initiated: April 14, 2014 #Z-1733-2014

Product Description

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.

Reason for Recall

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.

Details

Units Affected
4
Distribution
Worldwide Distribution: US Distribution to states of: IL, OH and TN; and country of: Italy.
Location
Newark, DE

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 4.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2014. Severity: Moderate. Recall number: Z-1733-2014.

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