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U.S. Department of Health and Human Services

Class 3 Device Recall Ventana Medical System's Symphony Staining System

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  Class 3 Device Recall Ventana Medical System's Symphony Staining System see related information
Date Initiated by Firm September 06, 2007
Date Posted January 09, 2008
Recall Status1 Terminated 3 on July 08, 2008
Recall Number Z-0300-2008
Recall Event ID 45437
Product Classification in vitro diagnostic - Product Code KEY
Product Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Ventana Medical Systems, Tucson, AZ
Code Information Serial Numbers: 910006-910011, 910013-910016, 910019, 910020, 910022, 910023, 910029, 910031-910033, 910036, 910049, 910053, 910054, 910056, 910057, and 910060.
Recalling Firm/
Manufacturer		 Ventana Medical Systems Inc
1910 E Innovation Park Dr
Tucson AZ 85755-1962
For Additional Information Contact Anita Wample
520-229-3975
Manufacturer Reason
for Recall		 Shock hazard: Devices released prior to full testing; the configuration of the Symphony instrument during Hi pot testing procedures did not completely evaluate all components in the test loop. In specific circumstances, a shock hazard exists.
FDA Determined
Cause 2		 Process control
Action On 9/6/07, the firm began visiting customers to perform the HiPot test. Prior to performing the High Potential Test of Symphony Instruments already in the Field, the Field Service Engineer or FSE ensures that the customer fully understands the purpose of the test and why it is necessary to perform the test at their site. The FSE conveys the following points regarding the HiPot test: - The HiPot test is a safety verification for the electrical path within the instrument. - The HiPot test was performed incorrectly during the manufacturing process. - The HiPot test is used to verify that if a high voltage overload condition were to occur it would not lead to a short/arc within the instrument, which could pose a risk to anyone that touches the instrument - The HiPot test places a voltage of 2,000VDC onto the high voltage path of the instrument and if any of the insulating components are compromised, the tester will notify the FSE of the condition. - If the instrument fails the HiPot test, the faulty component will be replaced and the instrument will be retested until it passes. - Due to the high voltage used the during the test, no one will be allowed to touch the instrument until the test is complete. The FSE performing the test documents that the customer was informed of the reason for the High Potential Test on their Field Service Report.
Quantity in Commerce 45 units
Distribution Worldwide: USA, Japan and France
Total Product Life Cycle TPLC Device Report
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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