| Class 2 Device Recall Dimension Vista Intelligent Lab Systems | |
Date Initiated by Firm | March 03, 2017 |
Date Posted | March 19, 2017 |
Recall Status1 |
Terminated 3 on July 03, 2018 |
Recall Number | Z-1703-2017 |
Recall Event ID |
76690 |
510(K)Number | K051087 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product | Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use
Product Usage:
The 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 multisensor technology for clinical use. |
Code Information |
Device Listing D011374 Serial Number: All serial numbers |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr Ms 514 PO BOX 6101 Newark DE 19702-2466
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For Additional Information Contact | 800-441-9250 |
Manufacturer Reason for Recall | Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential for an elevation of greater than 15 percent in the ECREA result. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Siemens mailed an Urgent Medical Device Correction Notice letter dated March 3, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens Technical Support Representative. |
Quantity in Commerce | 2733 systems |
Distribution | Worldwide Distribution - United States Nationwide and Puerto Rico, Canada, Qatar, Republic Korea, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, United Kingdom, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, and Portugal. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JJE
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