Z-1733-2014Class II

Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT...

Name: Z-1733-2014 Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-04-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-04-14 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista... on 2014-04-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1733-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Posted: 2014-06-09
Terminated: 2014-12-15
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), 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.
Root cause tag: manufacturing process
FDA 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 in commerce: 4
Distribution: Worldwide Distribution: US Distribution to states of: IL, OH and TN; and country of: Italy.
Product codes and lots: Product Siemens Material Number (SMN) Dimension Vista 500 Domestic: 10284473 International: 10488224 Dimension Vista 1500 Domestic: 10444801 International: 10444802 Serial #s: 0913900306 0913900355

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1733-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1733-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-09

Product code JJE

K051087Class IDimension Vista Integrated SystemDade Behring, Inc. / cleared 2005-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)