||June 09, 2014
|Recall Event ID
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
||Siemens Healthcare Diagnostics Vista Air Compressor
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 Siemens Material Number (SMN)
Dimension Vista¿ 500 Domestic: 10284473
Dimension Vista¿ 1500 Domestic: 10444801
|Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark, Delaware 19702-2466
|For Additional Information Contact
|Siemens Healthcare Diagnostics is recalling the Vista Air
Compressor replacement part: SMN 10706557 Desc: SKIT Air Compressor Assy,used on the Dimension Vista¿ 500 and Dimension Vista¿ 1500 systems because 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.
|COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
||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
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
||US Distribution IL, OH and TN. One Internationally to Italy.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = JJE and Original Applicant = DADE BEHRING, INC.