Siemens Healthcare Diagnostics, Inc.: 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.

Recall number

Z-1733-2014

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Status

Terminated

Initiated

2014-04-14

Posted

2014-06-09

Terminated

2014-12-15

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.

Root cause

Nonconforming Material/Component

Action

Siemens sent an Urgent Medical Device Correction letter dated April 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Actions to be Taken by the Customer 1. If an Air Compressor has already been delivered to your laboratory, or is delivered in the future for installation by your Siemens Healthcare Customer Service Engineer, please do not make any attempt to install the Air Compressor by yourself. 2. Please notify your local Siemens Healthcare Diagnostics Customer Care Center when an Air Compressor is at your site so arrangements may be made for installation by a Siemens Healthcare Diagnostics Customer Service Engineer. Please discuss the content of this letter with your Medical Director. Please complete and return the Field Correction Effectiveness Check Form attached to this letter. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens technical support representative.

Quantity

4

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K051087"]

PMA numbers

not on file

Product code

JJE

Firm FEI

2517506

Firm city

Newark

Firm state

DE

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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