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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical XRay System

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  Class 2 Device Recall Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical XRay System see related information
Date Initiated by Firm October 27, 2016
Create Date December 07, 2016
Recall Status1 Terminated 3 on July 30, 2020
Recall Number Z-0680-2017
Recall Event ID 75575
Product Classification X-ray fluorescence - Product Code RBY
Product Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System
Code Information Model - Vanta VCR
Recalling Firm/
Manufacturer		 Olympus Scientific Solutions Americas
48 Woerd Ave
Waltham MA 02453-3824
For Additional Information Contact
781-419-3900
Manufacturer Reason
for Recall		 Possible unintentional x-ray emission after users attempt early termination of the sequence.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 41 units located in the United States will consist of the following: 1. Shipments were stopped until a software correction was designed and validated. The software correction was designed by October 27, 2016, and was implemented on November 7, 2016 for all units that had not left the place of manufacture and for all new products. 2. The software correction will be made available to all distributors, sales personnel and users. Issue 1 is corrected by altering the behavior of the stop button and trigger such that they stop the current test and terminate the test sequence. To correct issue 2 the software will be modified to grey-out the Stop button during this very small period making it consistent with rest of the VANTA Start/Stop test UI paradigm. Both during user Start and Stop actions, users are shown a greyed button to acknowledge user Click and the button is un-greyed when the system completes the user operation. Both user operations typically take 100  400 milliseconds to complete. 3. All VANTA units in the United States are currently in the possession of Olympus or your distributors. No units are in the possession of users. 4. Olympus or its distributors will apply the software correction prior to delivering a VANTA system to any purchasers in the United States. For further questions, please call (781) 419-3900.
Quantity in Commerce 41 units
Distribution US Distribution to the states of : TX, WA, GA, MA, SC, AZ, PA, VA, CA, OH, NJ, MD, CO, IL, LA, and MN.
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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